Drug Recall List Last Updated: October 2021

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Drug Recall Details Contact Date Drug Recall Class*

Zonisamide Voluntary: Firm initiated If you have questions September Class 61919077530 about this recall, Direct 2021 II Rx, 1-678-619-5510

Metoprolol Tartrate Voluntary: Firm initiated If you have questions September Class 06586206499 about this recall, 2021 II Aurobindo Pharma USA Inc., 1-866-850-2876 Entacapone Voluntary: Firm initiated If you have questions September Class 00904682204 about this recall, The 2021 II Harvard Drug Group, 1- 800-875-0123. Valproic Acid Voluntary: Firm initiated If you have questions September Class 06043262116 about this recall, 2021 II Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 Promethazine With Codeine Voluntary: Firm initiated If you have questions September Class 06043260616 about this recall, 2021 II Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Promethazine Syrup Voluntary: Firm initiated If you have questions September Class 06043260816 about this recall, 2021 II Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 Arformoterol Tartrate Voluntary: Firm initiated If you have questions September Class 06846283365 about this recall, 2021 II 06846283335 Glenmark Pharmaceuticals Inc, 1-888-721-7115 Zonisamide Voluntary: Firm initiated If you have questions September Class 06846212901 about this recall, 2021 II 06846213001 Glenmark 06846213005 Pharmaceuticals Inc, 1-888-721-7115 Chlorzoxazone Voluntary: Firm initiated If you have questions September Class II 06846272401 about this recall, 2021 06846272501 Glenmark Pharmaceuticals Inc, 1-888-721-7115 Naproxen Sodium Voluntary: Firm initiated If you have questions September Class II 06846217801 about this recall, 2021 06846217901 Glenmark 06846217905 Pharmaceuticals Inc, 1-888-721-7115

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Fulvestrant Voluntary: Firm initiated If you have questions September Class II 06846231732 about this recall, 2021 Glenmark Pharmaceuticals Inc, 1-888-721-7115

Carbamazepine Voluntary: Firm initiated If you have questions September Class 00904617261 about this recall, The 2021 II Harvard Drug Group, 1- 800-875-0123. Betadine Solution Swabstick Voluntary: Firm initiated If you have questions September Class 06761815301 about this recall, 2021 II 06761815303 AVRIO HEALTH L.P, 1- 888-726-7535

Chantix (varenicline) Voluntary: Firm initiated If you have questions September Class 00069047103 about this recall, Pfizer 2021 II 00069046856 Inc.,1-800-438-1985. 00069046956 00069046903 Oxycodone Hydrochloride Presence of Foreign If you have questions September Class 04285800201 Tablets/Capsules; A single foreign about this recall, Akorn, 2021 II tablet Hydrochlorothiazide/Lisinopril Inc, Rhodes 25/20 was found in one bottle Pharmaceuticals, L.P., 1-401-262-9400, Prompt 2 Betamethasone Dipropionate Failed impurities/degradation If you have questions September Class 06174848030 specification: Out of Specification for about this recall, Akorn, 2021 II an unknown impurity observed in Inc, 1-800-932-5676, topical product. Prompt 2 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Naproxen Sodium Voluntary: Firm initiated If you have questions September II 06220776236 about this recall, 2021 Granules USA, Inc., 1877-770-3183 Clopidogrel Voluntary: Firm initiated If you have questions September II 03334206015 about this recall, 2021 Macleods Pharma Usa Inc, 1-888-943-3210 Cyclobenzaprine Hydrochloride Voluntary: Firm initiated If you have questions September II 00591333001 about this recall, 2021 07019901401 Teva Pharmaceuticals 05723726601 USA, 1-800-545-8800

FLUDARABINE PHOSPHATE Lack of Assurance of Sterility: the If you have questions September II FOR INJECTION manufacturing firm had microbial about this recall, 2021 02420123701 recoveries during environmental Custopharm, Inc., 1760- monitoring in aseptic areas of 683-0901 manufacturing.

Erythromycin Topical Solution Defective container: possibility for If you have questions September II 05256502759 lack of seal integrity. about this recall, Teligent 2021 Pharma, 1-856-697-1441

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Atovaquone Oral Suspension Temperature abuse: the firm received If you have questions September II 01070222321 customer complaints of unusual about this recall, 2020 grittiness in the product. KVK-Tech, Inc., 1-215- 579-1842 Carvedilol Presence of Foreign If you have questions September II 06838209505 Tablets/Capsules; report of two about this recall, 2021 70518182601 Paroxetine tablets were found in the RemedyRepack Inc., 1- bottle 866-845-3791

Adenosine Lack of Assurance of Sterility If you have questions August II 01671418001 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Leucovorin Calcium Lack of Assurance of Sterility If you have questions August II 00703514001 about this recall, 2021 00703514591 Teva Pharmaceuticals USA, 1-800-545-8800 Octreotide Acetate Lack of Assurance of Sterility If you have questions August II 00703331101 about this recall, 2021 00703330101 Teva Pharmaceuticals USA, 1-800-545-8800 Methylprednisolone Acetate Lack of Assurance of Sterility If you have questions August II 00703005101 about this recall, 2021 00703006301 Teva Pharmaceuticals USA, 1-800-545-8800 Alprostadil Lack of Assurance of Sterility If you have questions August II 00703150101 about this recall, 2021

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Teva Pharmaceuticals USA, 1-800-545-8800

Metoclopramide Lack of Assurance of Sterility If you have questions August II 00703450201 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Adenosine Injection Lack of Assurance of Sterility If you have questions August II 00703877601 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Norepinephrine Bitartrate Lack of Assurance of Sterility If you have questions August II 00703115301 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Epoprostenol Sodium Lack of Assurance of Sterility If you have questions August II 00703199501 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Leucovorin Calcium Lack of Assurance of Sterility If you have questions August II 00703514501 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Octreotide Acetate Lack of Assurance of Sterility If you have questions August II 00703333301 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Vecuronium Bromide Lack of Assurance of Sterility If you have questions August II 00703291401 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Idarubicin Hydrochloride Lack of Assurance of Sterility If you have questions August II 00703415611 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Amikacin Sulfate Lack of Assurance of Sterility If you have questions August II 00703904001 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Haloperidol Decanoate Lack of Assurance of Sterility If you have questions August II 00703713101 about this recall, 2021 00703713301 Teva Pharmaceuticals USA, 1-800-545-8800 Methylprednisolone Acetate Lack of Assurance of Sterility If you have questions August II 00703003101 about this recall, 2021 00703004301 Teva Pharmaceuticals 00703004501 USA, 1-800-545-8800 DAUNOrubicin Hydrochloride Lack of Assurance of Sterility If you have questions August II 00703523313 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 GaviLyteTM Failed Stability Specification; Out of If you have questions August II 04338606019 specification for Osmolarity about this recall, Lupin 2021 Pharmaceuticals Inc.1- 410-576-2000 ext 3

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Combipatch Failed Stability Specifications; out of If you have questions August II 06896805148 specification for shear. about this recall, 2021 06896805258 Noven Pharmaceuticals Inc, 1-305-253-5099

Tizanidine HCl Failed Tablet/Capsule Specification: If you have questions August II 05511118015 Some tablets are shaved about this recall, 2021 Dr. Reddy's Laboratories, Inc., 1-888-375-3784 Triamcinolone Acetonide Correct Labeled Product Mispack If you have questions August II 05256501480 about this recall, Teligent 2021 Pharma, 1-856-697-1441

Econazole Nitrate Correct Labeled Product Mispack If you have questions August II 05256501480 about this recall, Teligent 2021 Pharma, 1-856-697-1441

Ethosuximide Voluntary: Firm initiated If you have questions August II 00121067016 about this recall, PAI 2021 Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Cimetidine Hydrochloride Voluntary: Firm initiated If you have questions August II 00121064908 about this recall, PAI 2021 Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0

Nystatin Oral Voluntary: Firm initiated If you have questions August II 00121086816 about this recall, PAI 2021 00121086802 Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0

Venlafaxine Voluntary: Firm initiated August II 01671465701 2021

Sulfamethoxazole and Voluntary: Firm initiated If you have questions August II Trimethoprim about this recall, 2021 06586242005 Aurobindo Pharma USA Inc., 1-866-850-2876 Zyprexa Intramuscular, Voluntary: Firm initiated If you have questions August II Olanzapine about this recall, Eli Lilly & 2021 00002759701 Company. 1-317-276- 2000

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Chantix CGMP Deviations If you have questions August II 00069046856 about this recall, Pfizer 2021 00069047103 Inc.,1-800-438-1985. 00069046956 Estriol cGMP Deviations If you have questions August II 04614430001 about this recall, 2021 API Solutions Inc., 1-855-878-1489

NIFEdipine EXTENDED- Failed Dissolution Specification If you have questions July II RELEASE about this recall, Ingenus 2021 00904708061 Pharmaceutical. 1-877- 00904708006 748-1970

Solifenacin Succinate CGMP Deviations If you have questions July II 06909726102 about this recall, 2021 CIPLA, 1-866-604-3268.

Xylocaine-MPF with Epinephrine Low out of specification results for If you have questions July II 06332348737 epinephrine assay about this recall, 2021 06332348707 Genentech Inc, 1-888- 835-2555. Xolair (omalizumab) Failed Stability Specifications If you have questions July II 05024221501 about this recall, 2021 Fresenius Kabi USA, 1- 800-551-7176.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Buprenorphine and Naloxone Subpotent drug If you have questions July II Sublingual Film about this recall, Alvogen, 2021 04778135503 Inc. 1-866-770-3024

Topotecan Injection Presence of Particulate Matter If you have questions July I 00703471471 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Metformin Hydrochloride CGMP Deviations If you have questions June Class Extended-Release about this recall, 2021 II 07257803601 VIONA PHARMACEUTICALS INC, 1-888-304-5022 DermOtic Oil (fluocinolone Presence of Foreign Substance If you have questions June Class acetonide oil) about this recall, 2021 II 68791-103-20 Hill Dermaceuticals, Inc.,1-407-323-1998

Diflorasone Diacetate Ointment Presence of Foreign Substance If you have questions June Class 05256506315 about this recall, Teligent 2021 II 05256506330 Pharma, 1-856-697-1441

BusPIRone Hydrochloride Presence of Foreign If you have questions June Class 06958409310 Tablets/Capsules about this recall, Oxford 2021 II Pharmaceuticals, LLC, 1- 205-434-9649

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Micardis Subpotent Drug If you have questions June Class 0597004137 about this recall, 2021 II Boehringer Ingelheim Pharmaceuticals, Inc., 1- 908-927-1400 ChloraPrep With Tint 2% w/v Microbial Contamination of Non- If you have questions May Class chlorhexidine gluconate Sterile Product about this recall, 2021 I 005436540011 CareFusion 213, LLC, 1- 201-847-6800. ChloraPrep One-Step 2% w/v Microbial Contamination of Non- If you have questions May Class chlorhexidine gluconate Sterile Product about this recall, 2021 I 005436540001 CareFusion 213, LLC, 1- 201-847-6800. BD ChloraPrep Hi-Lite Orange 2 Non-sterility If you have questions May Class 05436540033 about this recall, 2021 I CareFusion 213, LLC, 1- 201-847-6800. BD ChloraPrep Clear Non-sterility If you have questions May Class 05436540032 about this recall, 2021 I CareFusion 213, LLC, 1- 201-847-6800. Estradiol Transdermal System Defective Delivery System If you have questions April Class 06896834378 about this recall, 2021 II Noven Pharmaceuticals Inc, 1-305-253-5099

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Minivelle Defective Delivery System If you have questions April Class 06896866758 about this recall, 2021 II Noven Pharmaceuticals Inc, 1-305-253-5099

Itraconazole Failed Dissolution Specifications If you have questions April Class 05974628230 about this recall, 2021 II Jubilant Cadista Pharmaceuticals, Inc., 1- 410- 860-2836 Riomet (metformin hydrochloride Microbial Contamination of Non- If you have questions April Class oral solution) Sterile Product about this recall, 2021 II 01063120602 SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555 Cefprozil Superpotent Drug If you have questions April Class 06818040201 about this recall, 2021 II 06818040202 Lupin Pharmaceuticals 06818040203 Inc., 1-866-587-4617 Guanfacine Extended-Release Cross Contamination If you have questions April Class 06050539281 about this recall, Apotex 2021 II 36050539281 Corp., 1 866.390-4411.

Mometasone Furoate CGMP Deviaitons If you have questions April Class 00713070185 about this recall, Cosette 2021 II 00713070153 Pharmaceuticals, Inc., 1 866.390-4411.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Neomycin Sulfate Failed Stability If you have questions April Class 03982203105 about this recall, 2021 II X-Gen Pharmaceuticals Inc., 1-866-390-4411. Telmisartan Labeling: Label-mixup If you have questions April Class 06233208730 about this recall, 2021 I Alembic Pharmaceuticals Limited, 1-908-393-9604 Progesterone Capsules Failed Dissolution Specifications If you have questions March Class 04359835001 about this recall, 2021 II Dr. Reddy's Laboratories, Inc., 1-888-375-3784 Metoclopramide Injection Chemical contamination If you have questions March Class 0703450204 about this recall, 2021 II Teva Pharmaceuticals USA, 1-800-545-8800 Famotidine Tablets Presence of foreign tablets/capsules If you have questions March Class 06586286099 about this recall, 2021 II Aurobindo Pharma USA Inc., 1-866-850-2876 Phenylephrine HCl Lack of Assurance of Sterility If you have questions March Class 02502131501 about this recall, Sagent 2021 II Pharmaceuticals Inc, 1- 866-625-1618 Gabapentin Failed Impurities/Degradation If you have questions March Class 05038331107 Specifications about this recall, Akorn, 2021 II Inc, 1-800-932-5676, Prompt 2

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nortriptyline HCL Failed Impurities/Degradation If you have questions March Class II 06191985330 Specifications about this recall, Direct 2021 Rx, 1-678-619-5510

Spironolactone Tablets Labeling: Label Mix-Up If you have questions March Class 63629106701 about this recall, 2021 II BRP Pharmaceuticals, 1- 877-885-0882

Daytrana (methylphenidate Defective Delivery System: Out of If you have questions March Class transdermal system) specification for mechanical peel about this recall, 2021 II 06896855523 Noven Pharmaceuticals 06896855533 Inc, 1-305-253-5099 06896855543 06896855553 Omeprazole Delayed Release Failed Impurities/Degradation If you have questions March Class Capsules Specifications about this recall, 2021 II 05199164310 Breckenridge Pharmaceutical, Inc, 1- 860-828-8140 Omeprazole Delayed Release Failed Impurities/Degradation If you have questions March Class Capsules Specifications about this recall, 2021 II 05140712910 Golden State Medical Supply Inc., 1-805-477- 9866 Fludeoxyglucose F 18 Lack of Assurance of Sterility If you have questions March Class 07631833450 about this recall, 2021 II

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Massachusetts General Hospital PET Center, 1- 617-726-2000

Irinotecan Hydrochloride CGMP Deviations If you have questions March Class 05992371402 about this recall, 2021 II Areva Pharmaceuticals Inc, 1-855-853-4760 Imatinib Mesylate Failed Dissolution Specifications If you have questions March Class 04359834490 about this recall, 2021 II 00435984431 Dr. Reddy's Laboratories, Inc., 1-888-375-3784 Epoprostenol Sodium Lack of Assurance of Sterility If you have questions March Class 00703199501 about this recall, 2021 II Teva Pharmaceuticals USA, 1-800-545-8800 Vecuronium Bromide Lack of Assurance of Sterility If you have questions March Class 00703291401 about this recall, 2021 II 00703291403 Teva Pharmaceuticals USA, 1-800-545-8800 Toposar Lack of Assurance of Sterility If you have questions March Class 00703565701 about this recall, 2021 II Teva Pharmaceuticals USA, 1-800-545-8800 Metoclopramide Injection Lack of Assurance of Sterility If you have questions March Class 00703450201 about this recall, 2021 II 00703450204 Teva Pharmaceuticals USA, 1-800-545-8800.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Leucovorin Calcium Lack of Assurance of Sterility If you have questions March Class 00703514001 about this recall, 2021 II 00703514501 Teva Pharmaceuticals USA, 1-800-545-8800. MethyIPREDNISolone Acetate Lack of Assurance of Sterility If you have questions March Class 00703003101 about this recall, 2021 II 00703005101 Teva Pharmaceuticals 00703005104 USA, 1-800-545-8800. 00703004501 00703004301 00703006301 Epoprostenol Sodium Lack of Assurance of Sterility If you have questions March Class 00703198501 about this recall, 2021 II Teva Pharmaceuticals USA, 1-800-545-8800. Sterile Diluent for Epoprostenol Lack of Assurance of Sterility If you have questions March Class Sodium about this recall, 2021 II 0703925801 Teva Pharmaceuticals USA, 1-800-545-8800. Desmopressin Acetate Lack of Assurance of Sterility If you have questions March Class 00703505101 about this recall, 2021 II 00703505103 Teva Pharmaceuticals USA, 1-800-545-8800. Dacarbazine Lack of Assurance of Sterility If you have questions March Class 00703507501 about this recall, 2021 II 00703507503 Teva Pharmaceuticals USA, 1-800-545-8800.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Cisatracurium Besylate Labeling: Label mix-up If you have questions March Class I 07128871206 about this recall, 2021 Meitheal Pharmaceuticals Inc, 1-224-443-4617. BD ChloraPrep Hi-Lite Orange Non-sterility If you have questions March Class I 2% w/v chlorhexidine gluconate about this recall, 2021 (CHG) and 70% v/v isopropyl CareFusion 213, LLC, 1- alcohol (IPA), Sterile Solution, 201-847-6800. 0.01 fl. oz 05436540033 ChlroraPrep One-Step 2% w/v Non-sterility If you have questions March Class I chlorhexidine gluconate (CHG) about this recall, 2021 and 70% v/v isopropyl alcohol CareFusion 213, LLC, 1- (IPA) Non-Sterile Solution -Clear, 201-847-6800. 0.10 fl. Oz 05436540001 ChloraPrep With Tint 2% w/v Microbial Contamination Class I chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi- Lite Orange, 0.10 fl. Oz 05436540011 BD ChloraPrep Clear, 2% w/v Non-sterility If you have questions March Class I chlorhexidine gluconate (CHG) about this recall, 2021 and 70% v/v isopropyl alcohol CareFusion 213, LLC, 1- (IPA) Sterile Solution, 0.10 fl 201-847-6800. 05436540032

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Meclizine HCl Tablets Failed Dissolution Specifications If you have questions February Class 05253612901 about this recall, Wilshire 2021 II 05253613301 Pharmaceuticals, Inc, Ltd, 1-877-495-6856. Cephalexin for Oral Suspension CGMP Deviations If you have questions February Class 06787754568 about this recall, Alkem 2021 II Laboratories, Ltd, 1-636- 343-5664. Metformin Hydrochloride CGMP Deviations If you have questions February Class Extended-Release Tablets about this recall, Nostrum 2021 II 02903305601 Laboratories Inc, 1-816- 841-4636. Nortriptyline HCl Capsules CGMP Deviations If you have questions February Class 05167240011 about this recall, Taro 2021 II Pharmaceuticals U.S.A., Inc.,1-800-544-1449 ext 6066. Acetaminophen Injection Discoloration and failed pH If you have questions February Class 05515030701 specifications about this recall, 2021 II AuroMedics Pharma LLC, 1-732-839-9400 ext 2. Ketorolac Tromethamine Presence of Particulate Matter If you have questions February Class Injection about this recall, 2021 I 06332316201 Fresenius Kabi USA, 1- 800-551-7176. Nitrofurantoin Capsules Failed Dissolution Specifications If you have questions January Class 06808444601 about this recall, American 2021 II 06808444611

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Health Packaging, 1-800- 707-4621.

Chlorhexidine Gluconate cGMP Deviations If you have questions January Class 06809402861 about this recall, Precision 2021 II Dose Inc., 1-800-397- 9228. Metformin Hydrochloride cGMP Deviations If you have questions January Class 02903305601 about this recall, Nostrum 2021 II Laboratories Inc, 1-816- 308-4941. Paroex (Chlorhexidine cGMP Deviations If you have questions January Class Gluconate) about this recall, Sunstar 2021 II 05237602102 Americas, Inc., 1-800-528- 05237602104 8527 Levetiracetam Defective container If you have questions January Class 05038324116 about this recall, Akorn, 2021 II Inc, 1-800-932-5676, Prompt 2 Cephalexin Failed Impurity/Degradation If you have questions January Class 06787754488 Specifications about this recall, 2021 II 06787754468 Ascend Laboratories LLC, 1-877-272-7901. Esomeprazole Magnesium Cross- contamination with other If you have questions January Class 06909752734 products about this recall, 2021 II 06909752834 CIPLA, 1-866-604-3268. 06909752934

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Cephalexin Failed Impurity/Degradation If you have questions January Class 06787754568 Specifications about this recall, Ascend 2021 II 06909752734 Laboratories LLC, 1-877- 272-7901. Auryxia (ferric citrate) CGMP Deviations If you have questions December Class 05992263101 about this recall, 2020 II Akebia Therapeutics dba Keryx Biopharmaceuticals, Inc, 1-617-871-2098. Hydroxyzine Hydrochloride Failed Impurities/Degradation If you have questions December Class 06043215004 Specification about this recall, 2020 II 06043215016 Morton Grove Pharmaceuticals, Inc., 1- 847-967-5600, Prompt 4.

Vumerity (diroximel fumarate) Failed dissolution specifications If you have questions December Class 06440602001 about this recall, 2020 II Biogen MA Inc., 1-844- 477-4672.

Lansoprazole Delayed-Release Failed Dissolution Specifications If you have questions December Class 06838277177 about this recall, 2020 II Zydus Pharmaceuticals (USA) Inc, 1-877-993- 8779, Prompt 2.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Lansoprazole Delayed-Release Failed Dissolution Specifications If you have questions December Class 06838277277 about this recall, 2020 II Zydus Pharmaceuticals (USA) Inc, 1-877-993- 8779, Prompt 2.

Sildenafil Product mix-up If you have questions December Class 04229174801 about this recall, 2020 II AVKARE Inc., 1-855-361- 3993.

TraZODONE Hydrochloride Product mix-up If you have questions December Class 04229183410 about this recall, 2020 II Shilpa Medicare Limited, 1-732-637-1971.

Imatinib Mesylate GMP Deviations If you have questions December Class 07248520330 about this recall, 2020 II Shilpa Medicare Limited, 1-732-637-1971. Imatinib Mesylate GMP Deviations If you have questions December Class 07248520290d about this recall, 2020 II Shilpa Medicare Limited, 1-732-637-1971. . Anagrelide Failed Dissolution Specifications If you have questions December Class I 01366846201 about this recall, 2020 Torrent Pharma Inc, 1- 888-280-2040. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

(Lidocaine HCL 2%) Topical Microbial Contamination of Non- If you have questions December Class I Anesthetic Hydrogel Sterile Drug Product about this recall, 2020 06697710703 MPM Medical LLC, 1-800- 232-5512. Chlorhexidine Gluconate Microbial contamination of non-sterile If you have questions December Class I 007016602715 products about this recall, 2020 Lohxa LLC, 1-800-641- 5564. Tizanidine Failed Dissolution Specifications If you have questions December Class I 06787761415 about this recall, Ascend 2020 Laboratories LLC, 1-877- 272-7901. Aripiprazole Failed Dissolution Specifications If you have questions December Class II 00904651204 about this recall, The 2020 Harvard Drug Group, 1- 800-875-0123. ARIPIPRAZOLE FAILED DISSOLUTION If you have questions December Class II 06042944930 SPECIFICATIONS about this recall, Golden 2020 State Medical Supply Inc., 1-805-477-9866. Paroex (chlorhexidine gluconate) Microbial Contamination of Non- If you have questions December Class I 05237602102 sterile Product about this recall, Sunstar 2020 05237602104 Americas, Inc., 1-609-751- 9600. Levetiracetam Presence of foreign tablet If you have questions December Class II 07193006352 about this recall, Jubilant 2020 EYWA PHARMA INC, 1- 609-751-9600.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. clomiPRAMINE Hydrochloride Failed Tablet If you have questions December Class II 05974671130 about this recall, Jubilant 2020 Cadista Pharmaceuticals, Inc., 1-800-308-3985. Lansoprazole Delayed-Release Failed Dissolution Specifications If you have questions November Class II Orally Disintegrating Tablets about this recall, Zydus 2020 06838277177 Pharmaceuticals, 1-877- 993-8779. Lansoprazole Delayed-Release Failed Dissolution Specifications If you have questions November Class II Orally Disintegrating Tablets about this recall, Zydus 2020 06838277277 Pharmaceuticals, 1-877- 993-8779. Mesalamine Delayed-Release Failed Dissolution Specifications If you have questions November Class II Tablets about this recall, Teva 2020 00591224522 Pharmaceuticals USA,1- 888-838-2872 ext 5 metformin HCL ER 750 mg CGMP Deviations If you have questions November Class II 04306390230 about this recall, PD-Rx 2020 04306390260 Pharmaceuticals, Inc., 1- 800-299-7379 metformin HCL ER 500 mg CGMP Deviations If you have questions November Class II tablets about this recall, PD-Rx 2020 07278900930 Pharmaceuticals, Inc., 1- 07278900960 800-299-7379 07278900993 07278900990

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Metformin Hydrochloride CGMP Deviations If you have questions November Class II Extended-Release Tablets about this recall, Nostrum 2020 02903305501 Laboratories Inc, 1-816- 841-4636. Metformin Hydrochloride CGMP Deviations If you have questions November Class II Extended-Release Tablets about this recall, Nostrum 2020 02903305601 Laboratories Inc, 1-816- 841-4636. Chlorhexidine Gluconate 20% Discoloration If you have questions November Class II 05329600120 about this recall, 2020 Medichem S.A., 1-201- 420-1800 Metformin Hydrochloride CGMP Deviations If you have questions November Class II Extended Release Tablets about this recall, 2020 04948362401 Medichem S.A., 631-753- 9090; ext. 160 Metformin Hydrochloride - CGMP Deviations If you have questions November Class II Extended-Release Tablets about this recall, 2020 04948362309 Marksans Pharma 04948362301 Limited, 631-753-9090; 04948362350 ext. 160 04948362310 04948362350

Metformin HCL E/R 500 mg CGMP Deviations If you have questions November Class II 07218906490 about this recall, Direct 2020 Rx, 1-678-619-5510

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Metformin Hydrochloride CGMP Deviations If you have questions November II Extended-Release Tablets, USP about this recall, Denton 2020 500 mg Pharma, Inc., 1-800-722- 07093430930 0772. 07093430960 07093430990 07093430998 Metformin Hydrochloride CGMP Deviations If you have questions November II Extended-Release Tablets about this recall, Denton 2020 07093433430 Pharma, Inc., 1-800-722- 0772. Mesalamine Delayed-Release Failed Dissolution Specifications If you have questions November II Tablets about this recall, AVKARE 2020 04229156412 Inc., 1-931-292-6222.

Metformin Hydrochloride CGMP Deviations If you have questions November II Extended Release 750 mg about this recall, 2020 70518248000 RemedyRepack Inc., 1- 866-845-3791 Hydrocortisone butyrate Cream, SUBPOTENT DRUG If you have questions November II 0.1% about this recall, 2020 06868227015 Boehringer Ingelheim Pharmaceuticals, Inc., 1- 908-927-1400 Catapres (clonidine An extraneous peak was observed If you have questions November II hydrochloride, USP) 0.3 mg for dissolution testing. about this recall, 2020 00597001101 Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Catapres (clonidine An extraneous peak was observed If you have questions November II hydrochloride, USP) 0.2 mg for dissolution testing. about this recall, 2020 00597000701 Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127 Catapres (clonidine An extraneous peak was observed If you have questions November II hydrochloride,USP) 0.1 mg for dissolution testing. about this recall, 2020 0597000601 Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127 NP Thyroid 120, Thyroid Tablets, Subpotent Drug If you have questions October I USP 2 grain (120 mg) about this recall, Acella 2020 04219232701 Pharmaceuticals, LLC1- 800-541-4802 ext 1, NP Thyroid 120, Thyroid Tablets, Subpotent Drug If you have questions October I USP 2 grain (120 mg) about this recall, Acella 2020 04219232801 Pharmaceuticals, LLC1- 800-541-4802 ext 1, Losartan Pot/HCTZ 50/12.5 mg CGMP Deviations If you have questions October II 06191904090 about this recall, Torrent 2020 Pharma Inc 1-800-912- 9561 RIOMET ER (metformin CGMP Deviations If you have questions October II hydrochloride for extended- about this recall, Sun 2020 release oral suspension) Pharmaceutical Industries, 01063101917 Inc., 1-800-818-4555

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Eye Itch Relief, Ketotifen CGMP Deviations If you have questions October II Fumarate Ophthalmic Solution about this recall, Akorn, 2020 0.035% Inc, 1-800-932-5676. 05977992001 Potassium Chloride Extended- Failed Dissolution Specifications If you have questions October II Release Tablets about this recall, 2020 06438086006 Strides Inc.1-609-773- 5000.

Nature-Throid, 1.5 Grain, (97.5 Subpotent Drug If you have questions September II mg), (Thyroid U.S.P. 1.5 gr. about this recall, 2020 (97.5mg)/Liothyronine (T3) Preferred 13.5mcg/Levothyroxine (T4) Pharmaceuticals, Inc. 1- 57mcg 714-777-3729. 68788760509

Nature-Throid, 1 Grain, 65 mg Subpotent Drug If you have questions September II (Thyroid U.S.P. 1 gr. about this recall, 2020 (65mg)/Liothyronine (T3) Preferred 9mcg/Levothyroxine (T4) 38mcg Pharmaceuticals, Inc. 1- 68788760409 714-777-3729. 68788760401 Nature-Throid, 3/4 Grain (48.75 Subpotent Drug If you have questions September II mg) Thyroid U.S.P. 3/4 gr. (48.75 about this recall, 2020 mg)/Liothyronine (T3) Preferred 6.75mcg/Levothyroxine (T4) Pharmaceuticals, Inc. 1- 28.5mcg 714-777-3729. 68788686009

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nature-Throid, 1/2 Grain, 32.5 Subpotent Drug If you have questions September II mg (Thyroid U.S.P. 1/2 gr. (32.5 about this recall, 2020 mg)/Liothyronine (T3) Preferred 4.5mcg/Levothyroxine (T4) Pharmaceuticals, Inc. 1- 19mch 714-777-3729. 68788928301 WP Thyroid, Westhroid Pure, 2 Subpotent Drug If you have questions September II Grain (130 mg) Thyroid USP about this recall, 2020 06472759502 RLC Labs Inc., 06472759504 1-877-797-7997 06472759505 06472759506 06472759501 WP Thyroid, Westhroid Pure, Subpotent Drug If you have questions September II 1.75 Grain (113.75 mg) Thyroid about this recall, 2020 USP RLC Labs Inc., 06472761502 1-877-797-7997 06472761504 06472761505 06472761506 06472761501 WP Thyroid, Westhroid Pure, 1.5 Subpotent Drug If you have questions September II Grain (97.5 mg) Thyroid USP about this recall, 2020 06472758502 RLC Labs Inc., 06472758504 1-877-797-7997 06472758505 06472758506 06472758501

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

WP Thyroid, Westhroid Pure, Subpotent Drug If you have questions September II 1.25 Grain (81.25 mg) Thyroid about this recall, 2020 USP RLC Labs Inc., 06472760502 1-877-797-7997 06472760504 06472760505 06472760506 06472760501 WP Thyroid, Westhroid Pure, 1 Subpotent Drug If you have questions September II Grain (65 mg) Thyroid USP about this recall, 2020 06472757502 RLC Labs Inc., 06472757504 1-877-797-7997 06472757505 06472757506 06472757501 WP Thyroid, Westhroid Pure, 1/2 Subpotent Drug If you have questions September II Grain (32.5 mg) Thyroid USP about this recall, 2020 06472755502 RLC Labs Inc., 06472755504 1-877-797-7997 06472755505 06472755506 06472755501 WP Thyroid, Westhroid Pure, Subpotent Drug If you have questions September II Thyroid USP, [liothyronine (T3) about this recall, 2020 2.25 mcg and levothyroxine (T4) RLC Labs Inc., 9.5 mcg 1-877-797-7997 06472754504 06472754505 06472754506 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

06472754501 06472754502

Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 27 mcg and about this recall, 2020 levothyroxine (T4) 114 mcg RLC Labs Inc., 06472733124 1-877-797-7997 06472733125 06472733126 06472733121 06472733122 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 22.5 mcg and about this recall, 2020 levothyroxine (T4) 95 mcg RLC Labs Inc., 06472733104 1-877-797-7997 06472733105 06472733106 06472733101 06472733102 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 20.25 mcg and about this recall, 2020 levothyroxine (T4) 85.5 mcg RLC Labs Inc., 06472733094 1-877-797-7997 06472733095 06472733096 06472733091 06472733092

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 18 mcg and about this recall, 2020 levothyroxine (T4) 76 mcg RLC Labs Inc., 06472733084 1-877-797-7997 06472733085 06472733086 06472733081 06472733082 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 15.75 mcg and about this recall, 2020 levothyroxine (T4) 66.5 mcg RLC Labs Inc., 06472733074 1-877-797-7997 06472733075 06472733076 06472733071 06472733072 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 13.5 mcg and about this recall, 2020 levothyroxine (T4) 57 mcg RLC Labs Inc., 06472733054 1-877-797-7997 06472733055 06472733056 00472733051 06472733052 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 11.25 mcg and about this recall, 2020 levothyroxine (T4) 47.5 mcg], RLC Labs Inc., 1.25 Grain (81.25 mg) 1-877-797-7997 06472733034 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

06472733035 06472733036 06472733031 06472733032

Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 4.5 mcg and about this recall, 2020 levothyroxine (T4) 19 mcg RLC Labs Inc., 06472732994 1-877-797-7997 06472732995 06472732996 06472732991 06472732992 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 6.75 mcg about this recall, 2020 06472733024 RLC Labs Inc., 06472733025 1-877-797-7997 06472733026 06472733021 06472733022 Nature-Throid, Thyroid USP Subpotent Drug If you have questions September II [liothyronine (T3) 9 mcg and about this recall, 2020 levothyroxine (T4) 38 mcg RLC Labs Inc., 06472733004 1-877-797-7997 06472733005 06472733006 06472733001 06472733002

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nature Throid, 1.5 Grain (97.5 Subpotent Drug If you have questions September I mg) Thyroid USP [Liothyronine about this recall, 2020 (T3) 13.5 mcg, Levothyroxine RLC Labs Inc., (T4) 57 mcg 1-877-797-7997 06472733054 06472733055 06472733056 06472733051 06472733051 Nature Throid, 2 Grain (130 mg) Subpotent Drug If you have questions September I Thyroid USP [Liothyronine (T3) about this recall, 2020 18 mcg, Levothyroxine (T4) 76 RLC Labs Inc., mcg 1-877-797-7997 06472733084 06472733081

Nature Throid, 1.25 Grain (81.25 Subpotent Drug If you have questions September I mg) Thyroid USP [Liothyronine about this recall, 2020 (T3) 11.25 mcg, Levothyroxine RLC Labs Inc., (T4) 47.5 mcg 1-877-797-7997 06472733031 Nature Throid, 3/4 Grain (48.75 Subpotent Drug If you have questions September I mg) Thyroid USP [Liothyronine about this recall, 2020 (T3) 6.75 mcg, Levothyroxine RLC Labs Inc., (T4) 28.5 mcg 1-877-797-7997 06472733021 06472733022

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nature Throid, 1/2 Grain (32.5 Subpotent Drug If you have questions September I mg) Thyroid USP [Liothyronine about this recall, 2020 (T3) 4.5 mcg, Levothyroxine (T4) RLC Labs Inc., 19 mcg 1-877-797-7997 06472732996 06472732991 WP Thyroid, Westhroid Pure, 1/2 Subpotent Drug If you have questions September I Grain (32.5 mg) Thyroid USP about this recall, 2020 [Liothyronine (T3) 4.5 mcg, RLC Labs Inc., Levothyroxine (T4) 19 mcg 1-877-797-7997 06472755504 06472755506 06472755501 Sulfamethoxazole and Presence of Foreign Substance: If you have questions September II Trimethoprim Tablets product complaints were received by about this recall, 2020 the firm for the presence of metal Aurobindo Pharma USA wire in the tablet(s). Inc., 1-866-850-2876 BusPIRone Hydrochloride Failed Impurity /Degradation If you have questions September II Tablets Specifications about this recall, 2020 Par Pharmaceutical Inc., 1-845-573-5500 Buprenorphine HCl Injection Sub-potent Drug: Out-of-Specification If you have questions September II assay results found at 3-month about this recall, 2020 stability testing. West-Ward Pharmaceuticals , 1-877-845-0689.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Metformin Hydrochloride CGMP Deviations If you have questions September II Extended-Release Tablets about this recall, 2020 07638512810 BAYSHORE PHARMACEUTICALS, 1- 877-372-6093 Metformin Hydrochloride CGMP Deviations If you have questions September II Extended-Release Tablets about this recall, 2020 07638512901 BAYSHORE PHARMACEUTICALS, 1- 877-372-6093 Cephalexin for Oral Suspension Labeling: Label Error on Declared If you have questions September II 00093417773 Strength about this recall, Teva 2020 Pharmaceuticals USA,1- 888-838-2872 ext 5

Lidocaine Patch 5% Labeling: Incorrect or Missing Lot If you have questions August II 00591352530 and/or Exp date on the individual about this recall, Teva 2020 transdermal pouches but not in the Pharmaceuticals USA,1- carton 888-838-2872 ext 5

Mibelas 24 Fe Failed Impurities/Degradation If you have questions August II 06818091113 Specifications: Out of specification about this recall, Lupin 2020 result observed in related substance Pharmaceuticals Inc.1- test 410-576-2000 ext 3

Nystatin Oral Suspension Subpotent drug: Out of specification If you have questions August II 00121061016 for assay at the 15-month test about this recall, PAI 2020 interval Holdings, LLC. dba Pharmaceutical * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Associates Inc1-864-277- 7282 ext 0

Ear Pain MD Pain Relief Drops cGMP Deviations. If you have questions August II 07242900708 about this recall, Eosera, 2020 Inc.1-844-732-7929

Ear Pain MD Pain Relief Drops cGMP Deviations. If you have questions August II 07242900722 about this recall, Eosera, 2020 Inc.1-844-732-7929

Heparin Sodium Subpotent Drug: Out-of-Specification If you have questions August II 70004065046 potency results at the 30-day stability about this recall, SCA 2020 timepoint. Pharmaceuticals1-877- 550-5059

BD ChloraPrep Clear Non-Sterility: Product is being If you have questions August I 5436540032213 recalled due to presence of about this recall, 2020 Aspergillus Penicilloides CareFusion LLC1-201- 847-6800.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

ChloraPrep With Tint Non-Sterility: Product is being If you have questions August I 05436540011 recalled due to presence of about this recall, 2020 Aspergillus Penicilloides CareFusion LLC1-201- 847-6800.

ChlroraPrep One-Step Non-Sterility: Product is being If you have questions August I 05436540001 recalled due to presence of about this recall, 2020 Aspergillus Penicilloides CareFusion LLC1-201- 847-6800.

DDAVP Nasal Superpotent Drug If you have questions August I 05556625000 about this recall, Ferring 2020 Pharmaceuticals Inc1- 888-337-7464 ext2

Desmopressin Acetate Superpotent Drug If you have questions August I 06991850105 about this recall, Ferring 2020 Pharmaceuticals Inc1- 888-337-7464 ext2

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

STIMATE (desmopressin Superpotent Drug If you have questions August I acetate) about this recall, Ferring 2020 00053687100 Pharmaceuticals Inc1- 888-337-7464 ext2

Hydrochlorothiazide CGMP Deviations: Light sensitive If you have questions August II 16729018317 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Hydrochlorothiazide (HCTZ) CGMP Deviations: Light sensitive If you have questions August II 29300012810 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Hydrochlorothiazide CGMP Deviations: Light sensitive If you have questions August II 16729018417 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Thyroid 1 Grain CGMP Deviations: Light sensitive If you have questions August II 64727330002 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Thyroid 1 Gr CGMP Deviations: Light sensitive If you have questions August II 64727330001 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Thyroid Neutral CGMP Deviations: Light sensitive If you have questions August II 64727330802 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Topiramate CGMP Deviations: Light sensitive If you have questions August II 47335070713 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Phendimetrazine CGMP Deviations: Light sensitive If you have questions August II 00702007710 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Phendimetrazine CGMP Deviations: Light sensitive If you have questions August II 69543041011 drug products repackaged in about this recall, Calvin 2020 transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545.

Phendimetrazine CGMP Deviations: Light sensitive If you have questions August Class 69543040911 drug products repackaged in about this recall, Calvin 2020 II transparent/partially transparent Scott & Company, Inc.1- pouches 800-545-6545. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Prednisone Labeling: Label Mix Up: bottle labeled If you have questions August Class 00527293137 to contain Prednisone Tablets about this recall, Lannett 2020 II Company, Inc.1-215-333- 9000

Elitek (rasburicase) Failed Stability Specifications: Out of If you have questions August Class II 00024515175 Specification result for enzyme about this recall, .Sanofi- 2020 activity levels noted during routine Aventis U.S. LLC1-800- stability testing 981-2491 ext 2 Mibelas 24 Fe Failed Impurities/Degradation If you have questions August Class 06818091111 Specifications: Out of specification about this recall, Lupin 2019 II result observed in related substance Pharmaceuticals Inc.1- test 410-576-2000 ext 3

Daptomycin Presence of Particulate Matter If you have questions August Class II 06745781350 about this recall, Mylan 2020 Institutional LLC, 1-800- 796-9526 ext 1. Fentanyl Citrate Lack of Assurance of Sterility If you have questions August Class II 00409909412 about this recall, Pfizer 2020 Inc.,1-800-438-1985.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Lisinopril Presence of Foreign If you have questions August Class II 06800133408 Tablets/Capsules about this recall, Lupin 2020 Pharmaceuticals Inc., 1- 866-587-4617 ext 2. Cefdinir Superpotent Drug If you have questions July Class II 06818072320 about this recall, Lupin 2020 Pharmaceuticals Inc., 1- 866-587-4617 ext 2. Metformin HCl Extended Release CGMP Deviation If you have questions July Class II Tablets about this recall, Preferred 2020 Pharmaceuticals, Inc, 1- 714-777-3729. Metformin Hydrochloride CGMP Deviation If you have questions July Class II Extended-Release about this recall, The 2020 00904579461 Time-Cap, Labs Inc, 1- 631-753-9090 ext 160 Clozapine Tablets Presence of foreign tablet If you have questions July Class II 06586284605 about this recall, 2020 Aurobindo Pharma USA, Inc, 1-866-850-2876 Metformin Hydrochloride CGMP Deviations If you have questions July Class II Extended-release Tablets about this recall, Lupin 2020 06818033607 Pharmaceuticals Inc., 1- 866-587-4617. Aripiprazole Tablets Labeling: Label mix up If you have questions July Class II 06233209730 about this recall, Alembic 2020 Pharmaceuticals Limited, 1-908-393-9604.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nystatin Cream Subpotent Drug If you have questions July Class II 00316022130 about this recall, Crown 2020 00316022115 Laboratories, Inc., 1-800- 877-8869. metFORMIN HCL ER CGMP Deviations If you have questions July Class II 07278900930 about this recall, Amneal 2020 07278900960 Pharmaceuticals., 1-833- 07278900990 582-0812. 07278900993 49483062301 Metformin Hydrochloride CGMP Deviations If you have questions July Class II Extended-Release Tablets about this recall, Time- 2020 04948362301 Cap Labs,1-631-753-9090 ext 160

Metformin Hydrochloride CGMP Deviations If you have questions July Class II Extended - Release Tablets about this recall, Teva 2020 06203757101 Pharmaceuticals USA, 1- 06203757110 800-545-8800. 06203757701 06203757710 Metformin Hydrochloride CGMP Deviations If you have questions July Class II Extended-Release Tablets about this recall, Amneal 2020 53746017801 Pharmaceuticals, 1-833- 06516217809 582-0812 06516217850 06516217810 53746017901 06516217910 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

00537460178 53746017805 53746017810 65162017811 00537460179 65162017901 Heparin Sodium Subpotent Drug If you have questions June Class II 70004065046 about this recall, SCA 2020 Pharmaceuticals, 1-877- 550-5059. Irinotecan HCL Injection Defective Container If you have questions June Class II 00143958301 about this recall, West- 2020 Ward Pharmaceutical Corp, 1-877-845-0689. Irinotecan HCL Injection Defective Container If you have questions June Class II 00143970101 about this recall, West- 2020 Ward Pharmaceutical Corp, 1-877-845-0689. metFORMIN HCL ER CGMP Deviations If you have questions June Class II 04306342830 about this recall, Amneal 2020 04306342860 Pharmaceuticals, 1-833- 04306342890 582-0812 04306342898 04306342893 53746017805 Metformin Hydrochloride CGMP Deviations If you have questions June Class II Extended-Release Tablets about this recall, AVKARE 2020 05026853115 Inc., 1-931-292-6222. 04229161090 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

04229161018 04229161036 04229161010

Metformin Hydrochloride CGMP Deviations If you have questions June Class II Extended-Release Tablets about this recall, AVKARE 2020 04229161190 Inc., 1-931-292-6222. 04229161118 04229161150 Metformin Hydrochloride CGMP Deviations If you have questions June Class II Extended-Release Tablets about this recall, Apotex 2020 06050502601 Inc., 1-800-268-4623.

Gaviscon Liquid Antacid Extra Labeling: Label lacks warning If you have questions June Class II Strength, Cool Mint about this recall, 2020 00135009541 Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 Gaviscon Extra Strength Liquid Labeling: Label lacks warning If you have questions June Class II Antacid Extra Strength Cherry about this recall, 2020 00135057441 Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 Gaviscon Regular Strength Labeling: Label lacks warning If you have questions June Class II Liquid Antacid Cool Mint about this recall, 2020 00135009441 Glaxosmithkline Consumer Healthcare * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Holdings Inc., 1-800-743- 4014

Gaviscon Regular Strength Labeling: Label lacks warning If you have questions June Class II Liquid Antacid Cool Mint about this recall, 2020 00135009442 Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 oxyTOCIN 30 Units Subpotent drug If you have questions June Class II 070092106807 about this recall, QuVa 2020 Pharma, Inc., 1-888-339- 0874. Lisinopril Product Mix Up If you have questions June Class II 06818051303 about this recall, Lupin 2020 Pharmaceuticals Inc., 1- 866-587-4617. Unasyn (ampicillin Presence of Particulate Matter If you have questions June Class II sodium/sulbacatam) about this recall, Pfizer 2020 00049001381 Inc., 1-800-879-3477. 00049001383 Doxycycline Hyclate Failed dissolution specification If you have questions June Class II 06258469311 about this recall, American 2020 Health Packaging, 1-614- 492-8177.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ketorolac Tromethamine Presence of Particulate Matter If you have questions June Class II 06332316200 about this recall, 2020 06332316203 Fresenius Kabi USA, LLC, 1-847-550-2300. Doxycycline Hyclate Failed Dissolution Specification If you have questions June Class II 00904043004 about this recall, The 2020 00904043006 Harvard Drug Group, 1- 732-542-1191. Dextroamphetamine Saccharate, Some bottles may contain mixed If you have questions June Class II Amphetamine Aspartate, strengths of the product. about this recall, Teva 2020 Dextroamphetamine Sulfate and Pharmaceuticals USA, 1- Amphetamine Sulfate 800-545-8800. 00555097102 00555097302 00555077702 Estriol USP Micronized Failed impurities/ degradation If you have questions June Class II 71092997702 specifications about this recall, TRIOVA 2020 PHARMACEUTICALS LLC, 1-539-777-0720. NP Thyroid 90 Superpotent Drug If you have questions June Class I 04219233101 about this recall, Acella 2020 Pharmaceuticals, LLC 1- 800-541-4802. NP Thyroid 60 Superpotent Drug If you have questions June Class I 04219233001 about this recall, Acella 2020 Pharmaceuticals, LLC 1- 800-541-4802.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

NP Thyroid 30 Superpotent Drug If you have questions June Class I 04219232901 about this recall, Acella 2020 Pharmaceuticals, LLC 1- 800-541-4802. Doxycycline Hyclate tablets Failed dissolution specifications If you have questions June Class II 05528986606 about this recall, PD-Rx 2020 05528986610 Pharmaceuticals, Inc., 1- 05528986614 800-299-7379. 05528986620 05528986628 05528986630 05528986660 05528986698 05528986671 05528986687 05528986674

Doxycycline Hyclate Tablets Failed dissolution specification If you have questions June Class II 00143211250 about this recall, West- 2020 00143211205 Ward Columbus Inc, 1- 877-845-0689. Lactated Ringers Presence of Particulate Matter If you have questions May Class II 0409795309 about this recall, Hospira 2020 Inc., 1-877-946-7747.

Aloprim (allopurinol sodium) Discoloration If you have questions May Class II 06745718750 about this recall, Mylan 2020 Pharmaceuticals Inc., 1- 551-233-2700. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Infuvite PEDiatric Pharmacy Defective container If you have questions May Class II 05464356470 about this recall, Sandoz, 2020 Inc, 1-609-627-8500

Epinephrine Injection CGMP Deviations If you have questions May Class II 00093598627 about this recall, Teva 2020 Pharmaceuticals USA, 1- 888-838-2872. Nizatidine CGMP Deviations If you have questions May Class II 06084630115 about this recall, Amneal 2020 Pharmaceuticals of New York, 1-631-952-0214 Ceftazidime Failed Stability Specifications If you have questions May Class II 00264314511 about this recall, Braun 2020 Medical Inc., 1-949-660- 2000 Lisinopril Tablets Product Mix-Up If you have questions April Class II 68180098103 about this recall, Lupin 2020 Pharmaceuticals Inc., 1- 866-587-4617 Cefixime for Oral Suspension Subpotent Drug If you have questions April Class II 06818040501 about this recall, Lupin 2020 Pharmaceuticals Inc., 1- 866-587-4617 Daytrana Defective Delivery System If you have questions April Class II 06896855553 about this recall, Noven 2020 Therapeutics, LLC, 1-305- 253-5099.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Daytrana Defective Delivery System If you have questions April Class II 06896855543 about this recall, Noven 2020 Therapeutics, LLC, 1-305- 253-5099. Daytrana Defective Delivery System If you have questions April Class II 06896855523 about this recall, Noven 2020 Therapeutics, LLC, 1-305- 253-5099. Acetaminophen and Codeine CGMP Deviations If you have questions April Class II Phosphate about this recall, 2020 01310705801 Aurobindo Pharma USA, Inc, 1-866-850-2876. Acetaminophen and Codeine CGMP Deviations If you have questions April Class II Phosphate about this recall, 2020 01310705999 Aurobindo Pharma USA, Inc, 1-866-850-2876. Acetaminophen and Codeine CGMP Deviations If you have questions April Class II Phosphate about this recall, 2020 01310706001 Aurobindo Pharma USA, Inc, 1-866-850-2876. Gabapentin Capsules CGMP Deviations If you have questions April Class II 06586219899 about this recall, 2020 Aurobindo Pharma USA, Inc, 1-866-850-2876. Levetiracetam Tablet CGMP Deviations If you have questions April Class II 06586224708 about this recall, 2020 Aurobindo Pharma USA, Inc, 1-866-850-2876.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Simvastatin CGMP Deviations If you have questions April Class II 06586205390 about this recall, 2020 Aurobindo Pharma USA, Inc, 1-866-850-2876. Mirtazapine CGMP Deviations If you have questions April Class II 01310703134 about this recall, 2020 06586219899 Aurobindo Pharma USA, Inc, 1-866-850-2876. Phentermine Hydrochloride CGMP Deviations If you have questions April Class II 06586205390 about this recall, 2020 06586219899 Aurobindo Pharma USA, Inc, 1-866-850-2876. Oxycodone and Acetaminophen CGMP Deviations If you have questions April Class II 01310704601 about this recall, 2020 6586219899 Aurobindo Pharma USA, Inc, 1-866-850-2876. Losartan Potassium CGMP Deviations If you have questions April Class II 06042931630 about this recall, Golden 2020 06042931690 State Medical Supply Inc., 06042931610 1-805-477-9866 Ext 4. Estradiol CGMP Deviations If you have questions April Class II 06327599008 about this recall, B & B 2020 06327599005 Pharmaceuticals, Inc., 1- 06327599004 800-499-3100. Acetaminophen and Codeine CGMP Deviations If you have questions April Class II Phosphate 300/30mg about this recall, H.J. 2020 52959000310 Harkins Co, 1-805-929- 52959000312 1333

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

52959000314 52959000315 52959000316 52959000320 52959000330 52959000360 succinylcholine Chloride lack of sterility assurance. If you have questions April Class II 07101934104 about this recall, 2020 PharMEDium Services, 1- 800-523-7749 Option 1 rocuronium Bromide lack of sterility assurance. If you have questions April Class II 07101932110 about this recall, 2020 07101932105 PharMEDium Services, 1- 800-523-7749 Option 1 Phytonadione Injectable Defective Container If you have questions April Class I Emulsion about this recall, Dr. 2020 04359840511 Reddy's Laboratories Inc., 1-888-375-3784 nICARdipine HCl lack of sterility assurance. If you have questions April Class II 07101920601 about this recall, 2020 PharMEDium Services, 1- 800-523-7749 Option 1 Losartan Potassium tablets CGMP Deviations If you have questions April Class II 00591374500 Teva Pharmaceuticals 2020 00591374600 USA, 1-888-483-8279 00591374700

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Losartan Potassium tablets CGMP Deviations If you have questions Avet April Class II 02315564503 Pharmaceuticals, Inc., 2020 02315564509 1-800-967-5952 Option 1 02315564510 02315564509 02315564603 02315564609 02315564610

Lisinopril Tablets Presence of Foreign Tablet/ Capsule If you have questions April Class II 06818098201 about this recall, Lupin 2020 Pharmaceuticals Inc., 1-800-399-2561

HYDROmorphone in 0.9% lack of sterility assurance. If you have questions April Class II Sodium Chloride HCl about this recall, 2020 06155316644 PharMEDium Services, 1- 800-523-7749 Option 1 Glycopyrrolate Tablets lack of sterility assurance. If you have questions April Class II 49884006501 about this recall, Par 2020 Pharmaceutical Inc., 1- 845-573-5500 fentaNYL Citrate Injection lack of sterility assurance. If you have questions April Class II 06155330633 about this recall, 2020 06155330328 PharMEDium Services, LLC, 1-800-523-7749 Option 1

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. fentaNYL Citrate lack of sterility assurance. If you have questions April Class II 06155311350 about this recall, 2020 06155367244 PharMEDium Services, LLC, 1-800-523-7749 Option 1 ePHEDrine Sulfate lack of sterility assurance. If you have questions April Class II 07103000312 about this recall, 2020 07103000309 PharMEDium Services, 07103000302 LLC, 1-800-523-7749 07103000109 Option 1

C-*Vancomycin Opthal 14 mg Lack of Assurance of Sterility If you have questions April Class II drops about this recall, Medical 2020 67457034001 Center Pharmacy, Inc., 1- 800-523-7749 C-*Gentamicin/Bacitracin Lack of Assurance of Sterility If you have questions April Class II Bladder Irrigation in N.S., 250 mL about this recall, Medical 2020 63323001002 Center Pharmacy, Inc., 1- 800-523-7749 C-*Albumin Eye Drop 10% S Lack of Assurance of Sterility If you have questions April Class II 44206025105 about this recall, Medical 2020 Center Pharmacy, Inc., 1- 800-523-7749 *Morphine 2 mg/mL Cassette Lack of Assurance of Sterility If you have questions April Class II 00409113403 about this recall, Medical 2020 Center Pharmacy, Inc., 1- 800-523-7749

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

*Mitomycin 0.04% Ophth DR eye Lack of Assurance of Sterility If you have questions April Class II drops about this recall, Medical 2020 067457051805 Center Pharmacy, Inc., 1- 800-523-7749 Nystatin Oral Suspension SubPotent Drug: Low out-of- If you have questions April Class II 00 21081016 specification results for assay testing. about this recall, PAI 2020 Holdings, LLC. dba Pharmaceutical Associates Inc, 1-864- 277-7282. Theophylline (Anhydrous) CGMP Deviations: poor If you have questions April Class II Extended-Release manufacturing practices resulted in about this recall, Jubilant 2020 02903300101 Labeling Draximage Inc, 1-800- 361-2356. DRAXIMAGE DTPA (KIT FOR Failed Stability Specifications If you have questions April Class II THE PREPARATION OF about this recall, Nostrum 2020 TECHNETIUM TC 99M Laboratories Inc, 1-816- PENTETATE INJECTION) 841-4636. 06517428805 06717528830 Advil Liqui-Gel Mini 160+20+20 Labeling: Lacks Warning or Rx If you have questions April Class II CT Legend- Certain lots does not include about this recall, 2020 00573171559 required safety warning information in Glaxosmithkline the Drug Facts Panel. Consumer Healthcare Holdings, +44 20 8047 5000.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ibuprofen 50 mg per 1.25 mL Labeling: Lacks Warning or Rx If you have questions April Class II Oral Suspension Advil Infant Legend- Certain lots does not include about this recall, 2020 Concentrated Drops White Grape required safety warning information in Glaxosmithkline 00573019175 the Drug Facts Panel. Consumer Healthcare 00573019150 Holdings, +44 20 8047 5000. Ibuprofen 200 mg liquid filled Labeling: Lacks Warning or Rx If you have questions April Class II capsules Advil Liqui-Gel Minis Legend- Certain lots does not include about this recall, 2020 00573176989 required safety warning information in Glaxosmithkline 00573176995 the Drug Facts Panel. Consumer Healthcare Holdings, +44 20 8047 5000. Advil Allergy & Congestion Relief Labeling: Lacks Warning or Rx If you have questions April Class II 00573019610 Legend- Certain lots does not include about this recall, 2020 required safety warning information in Glaxosmithkline the Drug Facts Panel. Consumer Healthcare Holdings, +44 20 8047 5000. Phenylephrine 10 mg tablets. Labeling: Lacks Warning or Rx If you have questions April Class II 00573019620 Legend- Certain lots does not include about this recall, 2020 required safety warning information in Glaxosmithkline the Drug Facts Panel. Consumer Healthcare Holdings, +44 20 8047 5000. Ibuprofen 200 mg Labeling: Lacks Warning or Rx If you have questions April Class II Chlorpheniramine Maleate 4mg Legend- Certain lots does not include about this recall, 2020 00573019610 required safety warning information in Glaxosmithkline the Drug Facts Panel. Consumer Healthcare

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Holdings, +44 20 8047 5000.

Doxycycline CGMP Deviations: During If you have questions March Class II 06330461501 manufacturing Solifenacin Succinate about this recall, Sun 2020 06330461650 Tablets might convert to Solifenacin Pharmaceutical Industries, Tartrate Tablets. Inc., 1-800-818-4555. Solifenacin Succinate CGMP Deviations: During If you have questions March Class II 05199189333 manufacturing Solifenacin Succinate about this recall, 2020 05199189390 Tablets might convert to Solifenacin Breckenridge Tartrate Tablets. Pharmaceutical, Inc, 1- 860-828 - 8140. Atorvastatin Calcium Presence of foreign substance: If you have questions March Class II 06330482905 Foreign matter has been identified as about this recall, Sun 2020 latex glove in one lot of Atorvastatin Pharmaceutical Industries, Calcium Tablets USP 40 mg. Inc., 1-800-818-4555. Pantoprazole Sodium Delayed- CGMP Deviations: Presence of dark If you have questions March Class II Release brown discoloration on edges of about this recall, Jubilant 2020 tablets Cadista Pharmaceuticals, Inc., 1-410- 860-2836. Sotalol HCL Presence of particulate matter. If you have questions March Class II 00378512301 presence of metal particles. about this recall, Mylan 2020 Pharmaceuticals Inc., 1- 551-233-2700. Daytrana (methylphenidate Defective Delivery System: Out of If you have questions March Class II transdermal system) specification for mechanical peel and about this recall, Noven 2020 06896855523 shear. Therapeutics, LLC, 1 - 06896855533 800-796-9526. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

06896855543 06896855553

Ranitidine CGMP Deviation; Possible If you have questions March Class II 00113785282 contamination with impurity N- about this recall, Perrigo 2020 05977954082 nitrosodimethylamine. Company PLC, 1-800- 03780850782 719-9260 02113011682 00363085282 Ranitidine CGMP Deviation; Possible If you have questions March Class II 05977995001 contamination with impurity N- about this recall, Perrigo 2020 nitrosodimethylamine. Company PLC, 1-800- 719-9260 Ranitidine CGMP Deviation; Possible If you have questions March Class II 00113785201 contamination with impurity N- about this recall, Perrigo 2020 06839185256 nitrosodimethylamine. Company PLC, 1-800- 05977954001 719-9260 05591001101 06398185256 03014260056 04125085201 01182208524 00363085201 Ranitidine CGMP Deviation; Possible If you have questions March Class II 04903580075 contamination with impurity N- about this recall, Perrigo 2020 01167395075 nitrosodimethylamine. Company PLC, 1-800- 719-9260

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine CGMP Deviation; Possible If you have questions March Class II 04903560875 contamination with impurity N- about this recall, Perrigo 2020 01167302375 nitrosodimethylamine. Company PLC, 1-800- 719-9260 Ranitidine CGMP Deviation; Possible If you have questions March Class II 00113795009 contamination with impurity N- about this recall, Perrigo 2020 05977995009 nitrosodimethylamine. Company PLC, 1-800- 04903580009 719-9260 04612253309 03014289109 03680095009 01167395009 00363095009 Ranitidine CGMP Deviation; Possible If you have questions March Class II 04152039209 contamination with impurity N- about this recall, Perrigo 2020 05977954009 nitrosodimethylamine. Company PLC, 1-800- 05531985209 719-9260 04612253209 03780850709 04934810954 0 4125089109 01182208523 03701285209 05059485209 04934810954 01167385209 00363085209

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine CGMP Deviation; Possible If you have questions March Class II 05591085271 contamination with impurity N- about this recall, Perrigo 2020 04612222471 nitrosodimethylamine. Company PLC, 1-800- 00113085271 719-9260 06925604171 03014260071 00904671651 04125085271 05606209971 01182208522 02113011671 03680085271 Ranitidine CGMP Deviation; Possible If you have questions March Class II 01167395058 contamination with impurity N- about this recall, Perrigo 2020 nitrosodimethylamine. Company PLC, 1-800- 719-9260 Ranitidine CGMP Deviation; Possible If you have questions March Class II 04125095002 contamination with impurity N- about this recall, Perrigo 2020 01182209500 nitrosodimethylamine. Company PLC, 1-800- 03701295062 719-9260 02113056862 03680095062 00363095002 Ranitidine CGMP Deviation; Possible If you have questions March Class II 04699485262 contamination with impurity N- about this recall, Perrigo 2020 04152039202 nitrosodimethylamine. Company PLC, 1-800- 05977954002 719-9260 05591085202 04116385262 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

04903560802 05530185202 05531985202 04612222462 00113085262 06925604162 04934810904 03014260002 00904671624 04125085202 05606209902 01182208525 01020285262 04119085262 03701285262 02113011602 05059485202 06201102821 03680085202 01167302302 00363085262

Ranitidine CGMP Deviation; Possible If you have questions March Class II 00113085251 contamination with impurity N- about this recall, Perrigo 2020 00363085251 nitrosodimethylamine. Company PLC, 1-800- 719-9260

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine CGMP Deviation; Possible If you have questions March Class II 06984229306 contamination with impurity N- about this recall, Perrigo 2020 nitrosodimethylamine. Company PLC, 1-800- 719-9260 Ranitidine CGMP Deviation; Possible If you have questions March Class II 03780887647 contamination with impurity N- about this recall, Perrigo 2020 04903587647 nitrosodimethylamine. Company PLC, 1-800- 719-9260

Ranitidine CGMP Deviation; Possible If you have questions March Class II 03780887647 contamination with impurity N- about this recall, Perrigo 2020 04903587647 nitrosodimethylamine. Company PLC, 1-800- 719-9260 Ranitidine CGMP Deviation; Possible If you have questions March Class II 00113787627 contamination with impurity N- about this recall, Perrigo 2020 07000003752 nitrosodimethylamine. Company PLC, 1-800- 01167387627 719-9260 00363187627 Ranitidine CGMP Deviation; Possible If you have questions March Class II 06201102832 contamination with impurity N- about this recall, Perrigo 2020 09046715524 nitrosodimethylamine. Company PLC, 1-800- 00125025272 719-9260 04934813612 Ranitidine CGMP Deviation; Possible If you have questions March Class II 06984229365 contamination with impurity N- about this recall, Perrigo 2020 04116393165 nitrosodimethylamine. Company PLC, 1-800- 05531987665 719-9260 00113087665 03780887665 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

06925687665 06201102831 06201102831 00904671546 02113011865 04934813644 01167387665 00363187665 Lisinopril/HCTZ Presence of Foreign If you have questions March Class II 68180051902 Tablets/Capsules about this recall, 2020 70518038203 RemedyRepack Inc., 1- 866-845-3791 Calcium Chloride Injection Lack of Assurance of Sterility If you have questions March Class II 07128302253 about this recall, Fusion IV 2020 Pharmaceuticals, Inc, 1- 877-685-8222 Cholecalciferol (Vitamin D3) Lack of Assurance of Sterility If you have questions March Class II Injection, VITAMIN D3 [P] 1,000 about this recall, Fusion IV 2020 IU/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128302103 877-685-8222 Zinc Chloride Injection, ZINC Lack of Assurance of Sterility If you have questions March Class II CHLORIDE 10MG/ML about this recall, Fusion IV 2020 INJECTABLE Pharmaceuticals, Inc, 1- 07128302243 877-685-8222 Cholecalciferol (Vitamin D3) Lack of Assurance of Sterility If you have questions March Class II Injection, VITAMIN D3 [P] about this recall, Fusion IV 2020 100,000 IU/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128302513 877-685-8222

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Elelyso (taliglucerase alfa) for Lack of Assurance of Sterility If you have questions March Class II injection about this recall, Pfizer 2020 069010601 Labs, 1-877-225-9750

Mesalamine Delayed-Release Failed Dissolution Specifications: If you have questions March Class II Tablets591224522 Low out of specification dissolution about this recall, Teva 2020 result observed during stability Pharmaceuticals USA, testing. Inc, 1-877-685-8222 Triamcinolone Diacetate Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 TRIAMCINOLONE DIACETATE Pharmaceuticals, Inc, 1- (PF) [2ML] CMC 40 MG/ML INJ 877-685-8222 SUSP, For IM, IA7 0128306282

Triamcinolone Diacetate Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 TRIAMCINOLONE DIACETATE Pharmaceuticals, Inc, 1- [10ML] CMC 80 MG/ML INJ 877-685-8222 SUSP, For IM, IA 07128306341

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Triamcinolone Acetonide (PF) Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 TRIAMCINOLONE ACETONIDE Pharmaceuticals, Inc, 1- (PF) [2ML] 40MG/ML INJ SUSP, 877-685-8222 For IM, IA7128306352

Triamcinolone Acetonide (PF) Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 TRIAMCINOLONE ACETONIDE Pharmaceuticals, Inc, 1- (PF) [10ML] 50MG/ML INJ 877-685-8222 SUSP, For IM, IA7128306331

Triamcinolone Lack of Assurance of Sterility If you have questions March Class II Acetonide/Bupivacaine about this recall, Fusion IV 2020 Hydrochloride Injectable Pharmaceuticals, Inc, 1- Suspension, TRIAMCINOLONE 877-685-8222 ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA 07128306321 Testosterone Cypionate Lack of Assurance of Sterility If you have questions March Class II Injection, TESTOSTERONE CYP about this recall, Fusion IV 2020 IN GRAPESEED OIL [1ML] 200 Pharmaceuticals, Inc, 1- MG/ML INJECTABLE 877-685-8222 07128305302

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Triamcinolone Acetonide (PF) Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 TRIAMCINOLONE ACETONIDE Pharmaceuticals, Inc, 1- (PF) [10ML] 50MG/ML INJ 877-685-8222 SUSP, For IM, IA 07128306331

Triamcinolone Diacetate Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 TRIAMCINOLONE Diacetate Pharmaceuticals, Inc, 1- [10ML] CMC 10MG/ML INJ 877-685-8222 SUSP, For IM, IA 07128306251l Testosterone Lack of Assurance of Sterility If you have questions March Class II Cypionate/Progesterone about this recall, Fusion IV 2020 Injection, TESTOSTERONE Pharmaceuticals, Inc, 1- CYP/PROGESTERONE [2ML] 877-685-8222 200MG/2.5MG/ML INJECTABLE7128305312

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Testosterone Cypionate Lack of Assurance of Sterility If you have questions March Class II Injection,TESTOSTERONE CYP about this recall, Fusion IV 2020 IN GRAPESEED OIL [10ML] 200 Pharmaceuticals, Inc, 1- MG/ML INJECTABLE 877-685-8222 07128305301 Selenium Injection, SELENIUM Lack of Assurance of Sterility If you have questions March Class II 200MCG/ML INJECTABLE about this recall, Fusion IV 2020 07128302273 Pharmaceuticals, Inc, 1- 877-685-8222 Super MIC Injection, SUPER Lack of Assurance of Sterility If you have questions March Class II MIC* INJECTABLE about this recall, Fusion IV 2020 07128302343 Pharmaceuticals, Inc, 1- 877-685-8222 Nicotinamide Adenine Lack of Assurance of Sterility If you have questions March Class II Dinucleotide (PF) Injection, about this recall, Fusion IV 2020 NICOTINAMIDE ADENINE Pharmaceuticals, Inc, 1- DINUCLEOTIDE (PF) 20 MG/ML 877-685-8222 INJECTABLE 07128303361

Iohexol (PF) Lack of Assurance of Sterility If you have questions March Class II Injection,OMNIPAQUE about this recall, Fusion IV 2020 INJECTION [5ML] 300MG I/ML Pharmaceuticals, Inc, 1- INJECTABLE 877-685-8222 07128314135

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pyridoxine Hydrochloride Lack of Assurance of Sterility If you have questions March Class II Injection, PYRIDOXINE HCL 100 about this recall, Fusion IV 2020 MG/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128302163 877-685-8222 Nicotinamide Adenine Lack of Assurance of Sterility If you have questions March Class II Dinucleotide (PF) Injection, about this recall, Fusion IV 2020 NICOTINAMIDE ADENINE Pharmaceuticals, Inc, 1- DINUCLEOTIDE (PF) 50 MG/ML 877-685-8222 INJECTABLE 07128303061 MIC-PLUS Injection, Vitamin Lack of Assurance of Sterility If you have questions March Class II Complex, MIC-COMBO* about this recall, Fusion IV 2020 25MG/50MG/50MG/1MG/20MG/ Pharmaceuticals, Inc, 1- 5MG/ML INJECTABLE 877-685-8222 07128302313

Mitomycin-C (PF) Irrigation Lack of Assurance of Sterility If you have questions March Class II Solution, MITOMYCIN-C (PF) 0.5 about this recall, Fusion IV 2020 MG/ML PF SYRINGE Pharmaceuticals, Inc, 1- 07128308128 877-685-8222

MIC-PLEX Injection, Vitamin Lack of Assurance of Sterility If you have questions March Class II Complex, MIC-COMBO* about this recall, Fusion IV 2020 25MG/50MG/50MG/1MG/20MG/ Pharmaceuticals, Inc, 1- 5MG/ML 877-685-8222 INJECTABLE7128302333

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

MIC-B12 Injection, MIC-B12 Lack of Assurance of Sterility If you have questions March Class II 25MG/50MG/50MG/1MG/ML about this recall, Fusion IV 2020 INJECTABLE7128302303 Pharmaceuticals, Inc, 1- 877-685-8222 Methylprednisolone Acetate Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 METHYLPREDNISOLONE Pharmaceuticals, Inc, 1- ACETATE [10ML] CMC 50 877-685-8222 MG/ML INJ SUSP, For IM, IA 07128306361 Methylprednisolone Acetate Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 METHYLPREDNISOLONE Pharmaceuticals, Inc, 1- ACETATE [10ML] CMC 100 877-685-8222 MG/ML INJ SUSP 07128306191 Methylprednisolone Lack of Assurance of Sterility If you have questions March Class II Acetate/Bupivacaine about this recall, Fusion IV 2020 Hydrochloride Injectable Pharmaceuticals, Inc, 1- Suspension 877-685-8222 07128306241

Methylprednisolone Acetate Lack of Assurance of Sterility If you have questions March Class II Injectable Suspension, about this recall, Fusion IV 2020 METHYLPREDNISOLONE Pharmaceuticals, Inc, 1- ACETATE (PF) CMC [2ML] 80 877-685-8222 MG/ML INJ SUSP, For IM, IA 07128306392

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Methylprednisolone Lack of Assurance of Sterility If you have questions March Class II Acetate/Bupivacaine about this recall, Fusion IV 2020 Hydrochloride Injectable Pharmaceuticals, Inc, 1- Suspension, METHYLPRED 877-685-8222 ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA 07128306231 Methylcobalamin Injection, Lack of Assurance of Sterility If you have questions March Class II METHYLCOBALAMIN [CD] about this recall, Fusion IV 2020 10MG/100MG/ML INJECTABLE, Pharmaceuticals, Inc, 1- For IV, IM 877-685-8222 07128303383

Methylcobalamin Injection, Lack of Assurance of Sterility If you have questions March Class II METHYLCOBALAMIN 1 MG/ML about this recall, Fusion IV 2020 INJECTABLE Pharmaceuticals, Inc, 1- 07128303313 877-685-8222

Lysine Hydrochloride Injection, Lack of Assurance of Sterility If you have questions March Class II LYSINE HCL 100MG/ML about this recall, Fusion IV 2020 INJECTABLE Pharmaceuticals, Inc, 1- 07128303423 877-685-8222 Levocarnitine Injection, Lack of Assurance of Sterility If you have questions March Class II LEVOCARNITINE 500 MG/ML about this recall, Fusion IV 2020 INJECTABLE Pharmaceuticals, Inc, 1- 07128392603 877-685-8222

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Lidocaine HCL (PF) Injection, Lack of Assurance of Sterility If you have questions March Class II LIDOCAINE HCL 4% (PF) 40 about this recall, Fusion IV 2020 MG/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128310115 877-685-8222

Polyoxyl Lauryl Ether Lack of Assurance of Sterility If you have questions March Class II (Polidocanol) Injection, about this recall, Fusion IV 2020 LAURETH-9 (POLIDOCANOL) Pharmaceuticals, Inc, 1- 5% INJECTABLE 877-685-8222 0712830603 Hydroxyprogesterone Caproate Lack of Assurance of Sterility If you have questions March Class II Injection, about this recall, Fusion IV 2020 HYDROXYPROGESTERONE Pharmaceuticals, Inc, 1- CAPROATE [4ML] 250 MG/ML 877-685-8222 INJECTABLE 07128305325

Arginine Hydrochloride Injection, Lack of Assurance of Sterility If you have questions March Class II L-ARGININE HCL 100MG/ML about this recall, Fusion IV 2020 INJECTABLE Pharmaceuticals, Inc, 1- 07128303413 877-685-8222

Human Chorionic Gonadotropin Lack of Assurance of Sterility If you have questions March Class II (hCG) Injection, HCG [10ML] about this recall, Fusion IV 2020 1000 IU/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128305331 877-685-8222

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Glycine Injection, GLYCINE USP Lack of Assurance of Sterility If you have questions March Class II 50MG/ML INJECTABLE about this recall, Fusion IV 2020 07128303443 Pharmaceuticals, Inc, 1- 877-685-8222 Glycerin (PF) Injection, Lack of Assurance of Sterility If you have questions March Class II GLYCERIN 99% INJECTABLE about this recall, Fusion IV 2020 07128304641 Pharmaceuticals, Inc, 1- 877-685-8222 Glutathione Lack of Assurance of Sterility If you have questions March Class II Injection,GLUTATHIONE about this recall, Fusion IV 2020 200MG/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128312313 877-685-8222

Hydroxocobalamin Injection, Lack of Assurance of Sterility If you have questions March Class II HYDROXOCOBALAMIN about this recall, Fusion IV 2020 5MG/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128303393 877-685-8222 Glutathione Lack of Assurance of Sterility If you have questions March Class II Injection,GLUTATHIONE about this recall, Fusion IV 2020 200MG/ML INJECTABLE Pharmaceuticals, Inc, 1- 07128312313 877-685-8222 Dexpanthenol Injection, Lack of Assurance of Sterility If you have questions March Class II DEXPANTHENOL 250 MG/ML about this recall, Fusion IV 2020 INJECTABLE Pharmaceuticals, Inc, 1- 07128302143 877-685-8222

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Dexamethasone (LA) Injectable Lack of Assurance of Sterility If you have questions March Class II Suspension, DEXAMETHASONE about this recall, Fusion IV 2020 LA [10ML] 16MG INJ SUSP Pharmaceuticals, Inc, 1- 07128306301 877-685-8222 Dexamethasone (LA) Injectable Lack of Assurance of Sterility If you have questions March Class II Suspension, DEXAMETHASONE about this recall, Fusion IV 2020 LA [10ML] 16MG INJ SUSP Pharmaceuticals, Inc, 1- 07128306301 877-685-8222 Deoxycholic Acid Sodium Lack of Assurance of Sterility If you have questions March Class II Injection, DEOXYCHOLIC ACID about this recall, Fusion IV 2020 SODIUM 1.67% INJECTABLE Pharmaceuticals, Inc, 1- 07128304623 877-685-8222 Cyanocobalamin Injection Lack of Assurance of Sterility If you have questions March Class II 07128303303 about this recall, Fusion IV 2020 Pharmaceuticals, Inc, 1- 877-685-8222 Cyanocobalamin/Folinic Acid Lack of Assurance of Sterility If you have questions March Class II Injection, CYANOCOBALAMIN : about this recall, Fusion IV 2020 FOLINIC ACID 2000 MCG/ML: Pharmaceuticals, Inc, 1- 500MCG/ML INJECTABLE 877-685-8222 07128303333 Injection,COENZYME Q-10 Lack of Assurance of Sterility If you have questions March Class II 20MG/ML OIL INJ SOLN about this recall, Fusion IV 2020 07128304111 Pharmaceuticals, Inc, 1- 877-685-8222 Biotin (Vitamin H) Injectable Lack of Assurance of Sterility If you have questions March Class II Suspension, BIOTIN 10 MG/ML about this recall, Fusion IV 2020 INJ SUSP, For IM

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

07128302203 Pharmaceuticals, Inc, 1- 877-685-8222

BETAMETHASONE Lack of Assurance of Sterility If you have questions March Class II ACETATE/BETAMETHASONE about this recall, Fusion IV 2020 (PF) Injectable Suspension, Pharmaceuticals, Inc, 1- Betamethasone 877-685-8222 Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA 07128306215 BETAMETHASONE Lack of Assurance of Sterility If you have questions March Class II ACETATE/BETAMETHASONE about this recall, Fusion IV 2020 (PF) Injectable Suspension, Pharmaceuticals, Inc, 1- Betamethasone 877-685-8222 Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA 07128306211 BETAMETHASONE Lack of Assurance of Sterility If you have questions March Class II ACETATE/BETAMETHASONE about this recall, Fusion IV 2020 (PF) Injectable Suspension, Pharmaceuticals, Inc, 1- Betamethasone 877-685-8222 Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, 07128306202

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

B-COMPLEX 110 INJECTABLE Lack of Assurance of Sterility If you have questions March Class II 07128302123 about this recall, Fusion IV 2020 Pharmaceuticals, Inc, 1- 877-685-8222 AscorbiX (Buffered C) Injection, Lack of Assurance of Sterility If you have questions March Class II Ascorbix (50ML) 500MG/ML about this recall, Fusion IV 2020 Injectable0 Pharmaceuticals, Inc, 1- 7128302265 877-685-8222

AscorbiX (Buffered C) Injection, Lack of Assurance of Sterility If you have questions March Class II Ascorbix (30ML) 500MG/ML about this recall, Fusion IV 2020 Injectable Pharmaceuticals, Inc, 1- 07128302263 877-685-8222

Alprostadil/Papaverine Lack of Assurance of Sterility If you have questions March Class II Hydrochloride/Phentolamine about this recall, Fusion IV 2020 Mesylate Injection Pharmaceuticals, Inc, 1- 07128305462 877-685-8222

Alprostadil (prostaglandin E1) 80 Lack of Assurance of Sterility If you have questions March Class II MCG/ML Injectable about this recall, Fusion IV 2020 07128305432 Pharmaceuticals, Inc, 1- 877-685-8222

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Alprostadil (prostaglandin E1)150 Patent ductus arteriosus If you have questions March Class II MCG/ML Injectable about this recall, Fusion IV 2020 027128305382 Pharmaceuticals, Inc, 1- 877-685-8222 Alprostadil/Papaverine Lack of Assurance of Sterility If you have questions March Class II Hydrochloride/Phentolamine about this recall, Fusion IV 2020 Mesylate/Atropine Sulfate Pharmaceuticals, Inc, 1- Injection 877-685-8222 07128305502

Alprostadil/Papaverine Lack of Assurance of Sterility If you have questions March Class II Hydrochloride/Phentolamine about this recall, Fusion IV 2020 Mesylate/Atropine Sulfate Pharmaceuticals, Inc, 1- Injection 877-685-8222 07128305492

Phenytoin Oral Suspension Resuspension Problems If you have questions March Class II 05167240691 about this recall, Taro 2020 Pharmaceuticals U.S.A, 1- 866-923-4914. Glycopyrrolate Tabs Failed Impurities If you have questions February Class II 00615817039 about this recall, NCS 2020 Healthcare of Kentucky Inc, 1-270-651-6188 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Desmopressin Acetate Tablets GMP Deviations If you have questions February Class II 06808460421 about this recall, American 2020 Health Packaging, 1-800- 967-5952. Desmopressin Acetate Tablets GMP Deviations If you have questions February Class II 06808460621 about this recall, American 2020 Health Packaging, 1-800- 967-5952. Lamotrigine Cross contamination If you have questions February Class II 05167241311 about this recall, Taro 2020 Pharmaceuticals U.S.A, 1- 866-923-4914. Methylphenidate hydrochloride Product bottle may be absent of If you have questions February Class II Extended-Release desiccant. about this recall, Teva 2020 06203772501 Pharmaceuticals, 1-888- 838-2872. Fentanyl Citrate Inj Defective container If you have questions February Class II 0409909412 about this recall, Pfizer 2020 Inc, 1-800-879-3477.

Ethacrynate Sodium for Injection cGMP Deviations If you have questions February Class II 06838224601 about this recall, Zydus 2020 Pharmaceuticals, 1-877- 993-8779. Caduet (amlodipine Defective container If you have questions February Class II besylate/atorvastatin calcium) about this recall, Pfizer 2020 00069218030 Inc, 1-800-879-3477.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Hydrocortisone and Acetic Acid Subpotent Drug If you have questions February Class II Otic about this recall, TECH 2020 05038390110 PHARMACAL CO., INC, 1-800-932-5676. Ranitidine Hydrochloride cGMP Deviations If you have questions February Class II 04306384414, about this recall, PD-Rx 2020 04306384430, Pharmaceuticals, Inc., 1- 04306384490, 405-942-3040. 04306384401 Olmesartan Medoxomil Tablets cGMP Deviations If you have questions February Class II 06787744690 about this recall, Ascend 2020 Laboratories LLC, 1-201- 476-1977. Atorvastatin Calcium Tablets Presence of Foreign Tablets If you have questions February Class II 07037702711 about this recall, Graviti 2020 Pharmaceuticals Private Limited, 040 6815 5555. Walgreens Acne Cleansing Bar, Presence of Foreign Substance If you have questions February Class II Benzoyl Peroxide 10% about this recall, Shandex 2020 00363013711 Personal Care Manufacturing Inc., 1-613- 267-1881 Nystatin Oral Suspension Subpotent If you have questions February Class II 00121081016 about this recall, 2020 Pharmaceutical Associates Inc, 1-864- 277-7282.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine Tablets CGMP Deviation If you have questions January Class II 70518171400 about this recall, 2020 RemedyRepack Inc, 1- 866-845-3791. Ranitidine Tablets Trace amounts of an impurity If you have questions January Class II 06878873883, about this recall, Preferred 2020 06878873889, Pharmaceuticals, Inc, 1- 06878873881, 714-777-3729. 06878863821, 06878863823, 06878863829, 06878863820 Nizatidine Capsules Trace amounts of an impurity If you have questions January Class II 00378515091, about this recall, Mylan 2020 00 378530093 Pharmaceuticals Inc, 1- 304-599-2595. Ranitidine Tablets Trace amounts of an impurity If you have questions January Class II 52959050207 about this recall, H.J. 2020 52959050214 Harkins Company, Inc, 1- 52959050220 800-841-5554. 52959050230 52959050260 Ranitidine Tablets Trace amounts of an impurity If you have questions January Class II 07093401704, about this recall, Denton 2020 07093401720, Pharma, Inc., 1-800-722- 07093401724, 0772. 07093401730, 07093401790, 07093428715, * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

07093428790

Netspot Defective container If you have questions January Class II 06948800140 about this recall, 2020 Advanced Accelerator Applications USA, Inc., 1- 862-263-0820. Estriol USP Micronized Subpotent If you have questions January Class II 62991215906, 62991215903, about this recall, Letco 2020 62991215905, 62991215902 Medical LLC, 1-800-239- 5288. Dutasteride cGMP Deviations If you have questions January Class II 5026828213 about this recall, AvKARE, 2020 Inc, 1-931-292-6222

Testosterone Cypionate cGMP Deviations If you have questions January Class II 06275601740,06275601540, about this recall, Sun 2020 06275601640 Pharmaceutical Industries, Inc., 1-609-495-2800. Sumatriptan Succinate Failed Impurities/Degradation If you have questions January Class II 06275652169, 06275652188 Specifications; out-of-specification about this recall, Sun 2020 results obtained for related Pharmaceutical Industries, substance. Inc., 1-609-495-2800. Ranitidine Impurities If you have questions January Class II 06255969060, 06255969005 about this recall, Appco 2020 Pharma LLC, 1-732-253- 7735. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine Impurities If you have questions January Class II 03780819601,03780819604 about this recall, AAA 2020 Pharmaceutical, Inc, 1- 609-288-6060. Blisovi Fe 1.5/30 Failed tablet If you have questions January Class II 06818086611 about this recall, Lupin 2020 Pharmaceuticals Inc, 1- 410-576-2000. Estriol Presence of impurities If you have questions January Class II 07642004936,07642004937, about this recall, 2020 07642004938 Asclemed USA Inc, 1-310- 320-0100. Ranitidine Presence of impurities If you have questions January Class II 06846224860,68486224860, about this recall, 2020 06846224801, 68486224860, Glenmark 06846224930, 68486224860, Pharmaceuticals Inc, 06846224901, 68486224860, 1-888-721-7115 06846224920, 68486224860, 06846224805, 68486224860 Ranitidine Presence of impurities If you have questions January Class II 06220777332 about this recall, Granules 2020 India Limited, 1-877-770- 3183. Myorisan® Unit dose mispackaging If you have questions January Class II 0 6174830213 about this recall, Akorn, 2020 Inc, 1-800-932-5676.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine Presence of impurities If you have questions January Class II 06068726069 about this recall, American 2020 Health Packaging, 1-800- 707-4621. Amantadine Hydrochloride Presence of foreign substance If you have questions December Class II 5974669901 about this recall, Jubilant 2019 Cadista Pharmaceuticals, Inc. 1-410-860-8500

25% Dextrose® Labeling error If you have questions December Class II 00409177510 about this recall, Pfizer 2019 Inc1-877-225-9750

Vancomycin Hydrochloride Product discoloration If you have questions December Class II 05515020420 about this recall, 2019 AuroMedics Pharma LLC, 888-238-7880. Lidocaine Hcl Presence of foreign substance If you have questions December Class II 70004072309 about this recall, SCA 2019 Pharmaceuticals, LLC, 1- 877-550-5059. Zantac® Presence of impurities If you have questions December Class II 06671597362, about this recall, Sanofi- 2019 06671597363,60671597368, Aventis U.S. LLC, 1- 800- 00597012201 00597012208, 633-1610 00597012213 00597012237, 00597012240 00597012254,

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

00597012261 00597012281, 00597012296

Regular Strength Zantac® Presence of impurities If you have questions December Class II 05026922225, 06775115101, about this recall, Sanofi- 2019 06775115201, 06775115202, Aventis U.S. LLC, 1- 800- 06815125840 633-1610

Maximum Strength Zantac® Presence of impurities If you have questions December Class II 00597012101, 00597012106, about this recall, Sanofi- 2019 00597012108, 00597012109, Aventis U.S. LLC, 1- 800- 00597012111, 00597012124, 633-1610 00597012138, 00597012150, 00597012164, 00597012166, 00597012168, 00059701218, 00597012180, 00597012182, 00597012185, 00597012190, 0059701294 Regular Strength Zantac® Presence of impurities If you have questions December Class II 04116703000, 04116703001, about this recall, Sanofi- 2019 04116703003, 04116703005, Aventis U.S. LLC, 1- 800- 04116703006, 04116703007, 633-1610 04116703008,00526922025

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Cool Mint Tablets Maximum Presence of impurities If you have questions December Class II Strength Zantac® about this recall, Sanofi- 2019 00597012006,00597012008, Aventis U.S. LLC, 1- 800- 00597012009,00597012024, 633-1610 00597012038,00597012050, 00597012076, 00597012078 00597012080,00597012082, 00597012087, 04116703201, 04116703202, 04116703203 04116703204,04116703205 04116703206, 04116703207 Ibuprofen Presence of foreign substance If you have questions December Class II 068788726801 about this recall, Preferred 2019 Pharmaceuticals Inc 1- 714-777-3729

Lidocaine hcl Presence of foreign substance If you have questions December Class II 05515016505 about this recall, 2019 AuroMedics Pharma, 1- 888-238-7880

Ranitidine Presence of impurities If you have questions December Class II 04229172460, 04229172530, about this recall, AvKARE, 2019 Inc, 1-931-292-6222

Ranitidine Presence of impurities If you have questions December Class II 06516225306, 06516225310, about this recall, Amneal 2019 06516225318, 06516225350,

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

06516225311, 06516225430, Pharmaceuticals, Inc., 1- 06516225410, 06516225425, 908-947-3120 06516266490, 05374625310, 05374625402

Ranitidine Presence of impurities If you have questions December Class II 068788707803, 068788707806 about this recall, Preferred 2019 Pharmaceuticals Inc 1- 714-777-3729

Ranitidine Presence of impurities If you have questions December Class II 05591009279 about this recall, 2019 Dolgencorp LLC, Inc, 1- 615-855-4000

Ranitidine Presence of impurities If you have questions December Class II 05965114460, 059651145-30, about this recall, 2019 06586243174, 05965114405, Aurobindo Pharma, 1-866- 850-2876

Walgreens Sodium Chloride Lack of Assurance of Sterility If you have questions November Class II Ophthalmic Solution about this recall, Altaire 2019 00363019313 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Walgreens Sodium Chloride Lack of Assurance of Sterility If you have questions November Class II Ophthalmic Ointment about this recall, Altaire 2019 00363750050

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Walgreen's Lubricant Eye Lack of Assurance of Sterility If you have questions November Class II Ointment, Mineral Oil about this recall, Altaire 2019 00363019150 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Support Harmony Lack of Assurance of Sterility If you have questions November Class II Lubricant Eye Drops about this recall, Altaire 2019 04903514510 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Support Advanced Lack of Assurance of Sterility If you have questions November Class II 04903588549 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Support Advanced Lack of Assurance of Sterility If you have questions November Class II Lubricating Eye Drops about this recall, Altaire 2019 04903588254 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Support Advanced Lack of Assurance of Sterility If you have questions November Class II Lubricant Gel Drops about this recall, Altaire 2019 0903588252 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Equate Sterile Lubricant Stye Lack of Assurance of Sterility If you have questions November Class II Ointment about this recall, Altaire 2019 04903587550 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Restore Tears Lubricant Lack of Assurance of Sterility If you have questions November Class II Eye Drops Twin Pack about this recall, Altaire 2019 04903518949 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Restore PM Nighttime Lack of Assurance of Sterility If you have questions November Class II Lubricant Eye Ointment about this recall, Altaire 2019 04903519150 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Night & Day Restore Lack of Assurance of Sterility If you have questions November Class II Tears Lubricant Eye Pack about this recall, Altaire 2019 04903588359 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Eye Allergy Relief Drops Lack of Assurance of Sterility If you have questions November Class II 4903587413 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Eye Allergy Relief Drops Lack of Assurance of Sterility If you have questions November Class II 04903588713 about this recall, Altaire 2019

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Equate Comfort Gel Lubricant Lack of Assurance of Sterility If you have questions November Class II Eye Gel about this recall, Altaire 2019 04903519749 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Puralube Petrolatum Ophthalmic Lack of Assurance of Sterility If you have questions November Class II Ointment® about this recall, Altaire 2019 00574402535 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Polycin (bacitracin zinc and Lack of Assurance of Sterility If you have questions November Class II polymyxin B sulfate) Ophthalmic about this recall, Altaire 2019 Ointment® Pharmaceuticals, Inc, 1- 00574402135 631-722-5988 Ext 16

Tetcaine (Tetracaine Lack of Assurance of Sterility If you have questions November Class II Hydrochloride) Ophthalmic about this recall, Altaire 2019 Solution® Pharmaceuticals, Inc, 1- 05479950215 631-722-5988 Ext 16

CVS Health Preservative Free Lack of Assurance of Sterility If you have questions November Class II Lubricant Eye Drops® about this recall, Altaire 2019 50428302958 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

TRP Stye Relief® Lack of Assurance of Sterility If you have questions November Class II 01731201413 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

TRP Pink Eye Relief® Lack of Assurance of Sterility If you have questions November Class II 01731201315 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

TRP Blur Relief Lack of Assurance of Sterility If you have questions November Class II 01731200211 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Perrigo Sulfacetamide Sodium Lack of Assurance of Sterility If you have questions November Class II Ophthalmic Ointment® about this recall, Altaire 2019 00574419035 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Perrigo Sterile Neo-Polycin HC Lack of Assurance of Sterility If you have questions November Class II (neomycin and polymixin B about this recall, Altaire 2019 sulfates, bacitracin zinc and Pharmaceuticals, Inc, 1- hydrocortisone acetate) 631-722-5988 Ext 16 Ophthalmic® 00574414435

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Perrigo Neo-Polycin neomycin Lack of Assurance of Sterility If you have questions November Class II and polymixin B sulfates and about this recall, Altaire 2019 bacitracin zinc Ophthalmic Pharmaceuticals, Inc, 1- Ointment® 631-722-5988 Ext 16 0574425035 Perrigo Neomycin and Polymixin Lack of Assurance of Sterility If you have questions November Class II B Sulfates and Dexamethasone about this recall, Altaire 2019 Ophthalmic® Pharmaceuticals, Inc, 1- 0574416035 631-722-5988 Ext 16

Perrigo Bacitracin Ophthalmic Lack of Assurance of Sterility If you have questions November Class II Ointment® about this recall, Altaire 2019 0574402235 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Ofloxacin Ophthalmic Solution Lack of Assurance of Sterility If you have questions November Class II 05939014005 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

OCuSOFT Tetravisc Tetracaine Lack of Assurance of Sterility If you have questions November Class II HCl 0.5% Sterile Anesthetic® about this recall, Altaire 2019 05479950505 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

OCuSOFT Tetravisc Tetracaine Lack of Assurance of Sterility If you have questions November Class II HCl 0.5% Sterile Anesthetic about this recall, Altaire 2019 05479950501®

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

OCuSOFT Tetravisc Forte Lack of Assurance of Sterility If you have questions November Class II Tetracaine HCl 0.5 % Sterile about this recall, Altaire 2019 Anesthetic® Pharmaceuticals, Inc, 1- 05479950405 631-722-5988 Ext 16

OCuSOFT Tetravisc Forte Lack of Assurance of Sterility If you have questions November Class II (Tetracaine HCl) 0.5% Sterile about this recall, Altaire 2019 Anesthetic® Pharmaceuticals, Inc, 1- 05479950401 631-722-5988 Ext 16

OCuSOFT Tears Again Sterile Lack of Assurance of Sterility If you have questions November Class II Lubricant Eye Drops® about this recall, Altaire 2019 05479990430 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Ocusoft Tears Again Lubricant Lack of Assurance of Sterility If you have questions November Class II Eye Drops ® about this recall, Altaire 2019 05479990415 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

OCuSOFT Homatropine Lack of Assurance of Sterility If you have questions November Class II Hydrobromide Ophthalmic about this recall, Altaire 2019 Solution® Pharmaceuticals, Inc, 1- 05479943105 631-722-5988 Ext 16

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ocusoft Goniosoft Hypromellose Lack of Assurance of Sterility If you have questions November Class II 2.5% Opthalmic Demulcent about this recall, Altaire 2019 Solution® Pharmaceuticals, Inc, 1- 05479950315 631-722-5988 Ext 16

OCuSOFT Flucaine Lack of Assurance of Sterility If you have questions November Class II Proparacaine Hydrochloride and about this recall, Altaire 2019 Fluorescein Sodium Ophthalmic Pharmaceuticals, Inc, 1- Solution® 631-722-5988 Ext 16 05479950721 OCuSOFT Eye Wash Sterile Lack of Assurance of Sterility If you have questions November Class II Isotonic Buffered Solution® about this recall, Altaire 2019 05479956501 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

OCuSOFT Eye Wash Sterile Lack of Assurance of Sterility If you have questions November Class II Isotonic about this recall, Altaire 2019 05479956559 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Natural Ophthalmics Women's Lack of Assurance of Sterility If you have questions November Class II Tear Stimulation Dry Eye Drops® about this recall, Altaire 2019 06877010315 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Natural Ophthalmics Tear Lack of Assurance of Sterility If you have questions November Class II Stimulation Forte Dry Eye about this recall, Altaire 2019 Drops®

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

06877010415 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Natural Ophthalmics Ortho-K Lack of Assurance of Sterility If you have questions November Class II Thin Eye Drops® about this recall, Altaire 2019 06877014415 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Natural Ophthalmics Ortho-K Lack of Assurance of Sterility If you have questions November Class II Thick Comfort Gel about this recall, Altaire 2019 06877014315 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Natural Ophthalmics Cataract Lack of Assurance of Sterility If you have questions November Class II Eye Drops® about this recall, Altaire 2019 06877013015 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Natural Ophthalmics Allergy Lack of Assurance of Sterility If you have questions November Class II Desensitization Eye Drops® about this recall, Altaire 2019 06877012015 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Nano Tears XP Clear Emollient Lack of Assurance of Sterility If you have questions November Class II Lubricant Gel Drops® about this recall, Altaire 2019 05939014351 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Nano Tears TF Clear Emollient Lack of Assurance of Sterility If you have questions November Class II Lubricant Gel Drops® about this recall, Altaire 2019 05939014249 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Nano Tears TF Clear Emollient Lack of Assurance of Sterility If you have questions November Class II Lubricant Gel Drops® about this recall, Altaire 2019 05939014156 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Lubricant Eye Drops Moisturizing Lack of Assurance of Sterility If you have questions November Class II Twin Pack® about this recall, Altaire 2019 00363018549 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 iSolutions NanoTears HA Lack of Assurance of Sterility If you have questions November Class II Preservative Free Multi - Dose about this recall, Altaire 2019 Lubricant Gel Drops® Pharmaceuticals, Inc, 1- 05939020810 631-722-5988 Ext 16 iSolutions Nano Tears XP Clear Lack of Assurance of Sterility If you have questions November Class II Emollient Lubricant Gel Drops® about this recall, Altaire 2019 05939014310 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 iSolutions Nano Tears TF Clear Lack of Assurance of Sterility If you have questions November Class II Emollient Lubricant Gel Drops® about this recall, Altaire 2019 05939014213

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 iSolutions Nano Tears TF Clear Lack of Assurance of Sterility If you have questions November Class II Emollient Lubricant Gel Drops® about this recall, Altaire 2019 05939014152 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 iSolutions Nano Tears MXP Lack of Assurance of Sterility If you have questions November Class II Forte Clear Emollient Lubricant about this recall, Altaire 2019 Gel Drops® Pharmaceuticals, Inc, 1- 05939014756 631-722-5988 Ext 16 iSolutions Nano Tears MXP Lack of Assurance of Sterility If you have questions November Class II Forte Clear Emollient Lubricant about this recall, Altaire 2019 Gel Drops® Pharmaceuticals, Inc, 1- 05939014410 631-722-5988 Ext 16 iSolutions Nano Tears MO Clear Lack of Assurance of Sterility If you have questions November Class II Emollient Lubricant Drops® about this recall, Altaire 2019 05939014510 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 iSolutions ActivEyes Nighttime Lack of Assurance of Sterility If you have questions November Class II Lubricant Eye Ointment® about this recall, Altaire 2019 05939019050 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

FreshKote Lubricant Eye Drops® Lack of Assurance of Sterility If you have questions November Class II 01582110115 about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altaire Sterile Eye Wash® Lack of Assurance of Sterility If you have questions November Class II 05939017513, 05939017535, about this recall, Altaire 2019 05939017518 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altaire Homatropaire Lack of Assurance of Sterility If you have questions November Class II Homatropine Hyrdobromide about this recall, Altaire 2019 Opthalmic Solution® Pharmaceuticals, Inc, 1- 05939019205 631-722-5988 Ext 16

Altaire Goniotaire Hypromellose Lack of Assurance of Sterility If you have questions November Class II 2.5% Opthlamic Demulcent about this recall, Altaire 2019 Solution® Pharmaceuticals, Inc, 1- 05939018213 631-722-5988 Ext 16

Altaire Fluorescein Sodium with Lack of Assurance of Sterility If you have questions November Class II Proparacaine Hydrochloride about this recall, Altaire 2019 Ophthalmic Solution Pharmaceuticals, Inc, 1- 05939020505® 631-722-5988 Ext 16

Altaire Diclofenac Sodium Lack of Assurance of Sterility If you have questions November Class II Opthalmic Solution® about this recall, Altaire 2019 5939014905

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altaire Diclofenac Sodium Lack of Assurance of Sterility If you have questions November Class II Opthalmic Solution® about this recall, Altaire 2019 05939014902 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altaire Ciprofloxacin Ophthalmic Lack of Assurance of Sterility If you have questions November Class II Solution® about this recall, Altaire 2019 05939021710 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altaire Ciprofloxacin Ophthalmic Lack of Assurance of Sterility If you have questions November Class II Solution® about this recall, Altaire 2019 05939021702 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altaire Ciprofloxacin HCl Lack of Assurance of Sterility If you have questions November Class II Ophthalmic Solution® about this recall, Altaire 2019 05939021705 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

Altacaine (Tetracaine Lack of Assurance of Sterility If you have questions November Class II Hydrochloride) Ophthalmic about this recall, Altaire 2019 Solution ® Pharmaceuticals, Inc, 1- 05939018113 631-722-5988 Ext 16

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

ActivEyes Sterile Altalube Lack of Assurance of Sterility If you have questions November Class II Ointment® about this recall, Altaire 2019 05939019850 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Preservative Free Lack of Assurance of Sterility If you have questions November Class II Multi-Dose Lubricant Gel Drops® about this recall, Altaire 2019 05939014852 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Preservative Free Lack of Assurance of Sterility If you have questions November Class II Multi-Dose Lubricant Drops® about this recall, Altaire 2019 05939014652 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Sterile Altalube Lack of Assurance of Sterility If you have questions November Class II Ointment® about this recall, Altaire 2019 05939019850 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Preservative Free Lack of Assurance of Sterility If you have questions November Class II Multi-Dose Lubricant Drops® about this recall, Altaire 2019 05939014652

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Lubricant Eye Lack of Assurance of Sterility If you have questions November Class II Ointment® about this recall, Altaire 2019 05939018950 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Altachlore Solution Lack of Assurance of Sterility If you have questions November Class II 05939018313® about this recall, Altaire 2019 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16

ActivEyes Altachlore Sodium Lack of Assurance of Sterility If you have questions November Class II Chloride Hypertonicity Opthalmic about this recall, Altaire 2019 Ointment® Pharmaceuticals, Inc, 1- 05939018450 631-722-5988 Ext 16

Ranitidine impurity detected If you have questions November Class II 05140709705 about this recall, Golden 2019 State Medical Supply Inc. 1-805-477-9866

Novitium Pharma Ranitidine® impurity detected If you have questions November Class II 07095400120 about this recall, Novitium 2019 07095400140 Pharma LLC. 1-855-204- 07095400210 1431 07095400240 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Rite Aid Pharmacy Maximum Possible contamination If you have questions November Class II Strength Ranitidine ® about this recall, Apotex 2019 01182260522 Inc. 1-800-706-5575 01182260518 Equate Maximum Strength Possible contamination If you have questions November Class II Ranitidine® about this recall, Apotex 2019 04903511706 Inc. 1-800-706-5575

Rite Aid Pharmacy Maximum Possible contamination If you have questions November Class II Strength Ranitidine® about this recall, Apotex 2019 01182261074 Inc. 1-800-706-5575

Equate Maximum Strength Possible contamination If you have questions November Class II Ranitidine® about this recall, Apotex 2019 04903510007 Inc. 1-800-706-5575 04903510000 Walgreens Regular Strength Possible contamination If you have questions November Class II Wal-Zan 75 Ranitidine® about this recall, Apotex 2019 00363102903 Inc. 1-800-706-5575

Walgreens Maximum Strength Possible contamination If you have questions November Class II Wal-Zan 150 Ranitidine® about this recall, Apotex 2019 00363103007 Inc. 1-800-706-5575 00363103006

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Alprazolam tablets Presence of foreign substance If you have questions November Class II 00378400305 about this recall, Mylan 2019 Pharmaceuticals. 1-304- 599-2595

Ranitidine tablets Impurity detected in product. If you have questions November Class II 00363001061 ,00363001062 about this recall, Dr. 2019 ,00363001001, 04903540461, Reddy's Laboratories, Inc. 04903540413,04903540465, 1-309-375-9900 03014250534, 03014250550, 00150062076, 06984287130, 06984287180,06984287137, 03014213130, 06386848230, 06386848260, 04359880862 04359880865, 07171320302 07171320305, 05789671524, 01167384940, 05511113160, 05511140434, 00363013130 00363013180, 06386848024 06386848050, 05789671705 Ranitidine capsules Impurity detected in product. If you have questions November Class II 05511112960, 05511112905, about this recall, Dr. 2019 05511113030, 05511113001 Reddy's Laboratories, Inc. 1-309-375-9900

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Atorvastatin calcium Presence of foreign substance If you have questions November Class II 06050525808 about this recall, Apotex, 2019 Inc. 1-800-706-5575

Gatifloxacin Ophthalmic Labeling error If you have questions November Class II Solution® about this recall, Sandoz, 2019 06131467225 Inc. 1-609-627-8500

Neomycin and Polymyxin B Incorrect or missing package insert If you have questions November Class II Sulfates and Dexamethasone about this recall, Sandoz, 2019 Ophthalmic Suspension Inc. 1-609-627-8500 06131463006 Bimatoprost Ophthalmic Solution Incorrect or missing package insert If you have questions November Class II 00781620675 about this recall, Sandoz, 2019 Inc. 1-609-627-8500

Testosterone Cypionate Injection Labeling error If you have questions November Class II 05253662501 about this recall, Arbor 2019 Pharmaceuticals. 1-866- 284-8792

Ranitidine tablets Empty bottles If you have questions November Class II 05591009279 about this recall, 2019 AuroMedeics Pharma LLC.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ranitidine hydrochloride Impurities If you have questions November Class II capsules about this recall, AvKare, 2019 04229173550,04229173650 Inc. 1-931-292-6222

Estradiol vaginal inserts Impurities If you have questions November Class II 06846271188 about this recall, Glenmark 2019 Pharmaceuticals. 1-888- 721-7115

Prasugrel tablets® Failed dissolution specification If you have questions November Class II 00378518593 about this recall, Mylan 2019 Pharmaceuticals. 1-304- 599-2595

Ibuprofen suspension Presence of foreign substance If you have questions November Class II 05167213858,05167221308, about this recall, Taro 2019 51672138509,05167221301, Pharmaceuticals. 1-866- 6709132104 923-4914

Leucovorin Calcium Presence of particulate matter If you have questions October Class II 05074246450 about this recall, Ingenus 2019 Pharmaceutical. 1-877- 748-1970

Pioglitazone Hydrochloride Superpotent If you have questions October Class II 03334205407 about this recall, Macleods 2019

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals Ltd, 91- 22-6676-2800

Dextroamphetamine Sacharate, Superpotent Drug: Amphetamine If you have questions October Class II Amphetamine Aspartate, Mixed Salts 20mg have been found about this recall, 2019 Dextroamphetamine Sulfate and to be out of specification for weight Aurobindo Pharma USA Amphetamine Sulfate and thickness. Inc. 1-732-839-9400 01310707301 Fentanyl Citrate® Potential contamination If you have questions October Class II 49452003206 about this recall, Spectrum 2019 Laboratory Products. 1- 800-772-8786

Ascorbic Acid Labeling issue If you have questions Class II 07159150050 about this recall, Atlas October Pharmaceutical. 1-410- 2019 860-8500

Pantoprazole Sodium Delayed Discoloration on edges of tablets If you have questions October Class II Release about this recall, Jubilant 2019 05974628490 Cadista Pharmaceuticals, Inc. 1-410-860-8500

Vivitrol® Mislabeling If you have questions September Class II 65757030001 about this recall, Alkermes, 2019 Inc. 1-800-848-4876

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Relpax® Microbial contamination If you have questions September Class II 00049234005, 00049234045 about this recall, Pfizer 2019 Inc1-877-225-9750

Hydrocortisone cream with aloe, Potential microbial contamination If you have questions August Class II Hydrocortisone about this recall, US 2019 00363062003, 00363062004 Pharmaceuticals Inc. 1- 888-337-7464

Lisinopril and hydrochlorothiazide Brownish/blackish stains on the If you have questions August Class II tablets tablets about this recall, Lupin 2019 68180051801, 68180051802 Limited 1-866-587-4617

Nitrofurantoin Failed dissolution specifications If you have questions August Class II monohydrate/macrocrystals about this recall, Alvogen, 2019 capsules Inc. 1-866-770-3024 47781030301 Macrobid Urinary Tract Failed dissolution specifications If you have questions August Class II Antibacterial about this recall, Alvogen, 2019 52427028501 Inc. 1-866-770-3024

Aspirin and extended-release Failed impurities/degradation If you have questions August Class II dipyridamole capsules specifications about this recall, American 2019 60687030532 Health Packaging 1-614- 492-8177

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Doxycycline hyclate Failed dissolution specifications If you have questions August Class II 62584069321 about this recall, American 2019 Health Packaging

Neomycin 3.5 mg/g / polymyxin Insufficient quality If you have questions July 2019 Class II b10000 usp units/g / about this recall, H.J. dexamethasone 1 mg/g Harkins Company 1-805- ophthalmic ointment 929-1333 52959040701 Diphenhydramine Contamination If you have questions July 2019 Class II 49035033002, 49035033096, about this recall, LNK 49035033045 International 1-631-543- 3787

Norethindrone and ethinyl Failed Impurities If you have questions July 2019 Class II estradiol about this recall, Lupin 68180090313 Pharmaceuticals 1-800- 399-2561

Milrinone lactate Bags have the potential to leak If you have questions July Class II 00409277602, 00409277623 about this recall, Pfizer Inc. 2019 1-800-879-3477

Fluorouracil injection Glass Particles If you have questions June Class I 63323011710, 63323011719, about this recall, Fresenius 2019 63323011728, 63323011761, Kabi 1-888-386-1300 63323011761, 63323011769, 63323011718, 63323011720,

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

63323011751, 63323011759, 63323011768

Heparin Sodium® Not potent If you have questions June Class II 00264958720 about this recall, Braun 2019 Medical Inc 1-800-523- 9676

Estradiol vaginal inserts Defective delivery If you have questions June Class II 68462071171, 68462071188 about this recall, Glenmark 2019 Pharmaceuticals Inc 1-201-684-8000

Zyflo Cr® Failed dissolution If you have questions June Class II 10122090212, 10122090220 about this recall, Chiesi 2019 USA, 1-919-678-6611

Pramipexole dihydrochloride Possible cross contamination If you have questions May Class II 68084079325, 68084097425 about this recall, American 2019 Health Packaging, 1-800- 707-4621

Zileuton® Failed dissolution If you have questions May Class II 66993048532 about this recall, Chiesi 2019 USA, 1-919-678-6611

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Testosterone Lack of sterility If you have questions May Class II 69699170230, 69699170210 about this recall, Pharm D. 2019 Solutions 1-713-790-1693

Hydrocodone bitartrate and Contamination with burkholderia If you have questions May Class II homatropine methylbromide oral about this recall, Torrent 2019 solution Pharma Inc 1-800-912- 59741026216, 13668057710 9561

Risperidone Contamination with burkholderia If you have questions May Class II 23155031751 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Cetirizine hydrochloride Contamination with burkholderia If you have questions May Class II 23155029251, 23155029252, about this recall, Torrent 2019 13668059607, 13668059611 Pharma Inc 1-800-912- 9561

Phenylephrine hydrochloride Contamination with burkholderia If you have questions May Class II 00536138912, 00536138935, about this recall, Torrent 2019 00904768822 Pharma Inc 1-800-912- 9561

Bisacodyl Contamination with burkholderia If you have questions May Class II 00536135501, 00536135512 about this recall, Torrent 2019

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharma Inc 1-800-912- 9561

Hydrocortisone acetate Contamination with burkholderia If you have questions May Class II suppositories about this recall, Torrent 2019 59741030101, 59741030124, Pharma Inc 1-800-912- 59741030112 9561

Memantine hydrochloride Contamination with burkholderia If you have questions May Class II 39328055112 about this recall, Torrent 2019 13668057309 Pharma Inc 1-800-912- 9561

Lactulose solution Contamination with burkholderia If you have questions May Class II 13668058008, 13668058012, about this recall, Torrent 2019 13668057408, 13668057412, Pharma Inc 1-800-912- 13668057410 9561

Pseudoephedrine Hydrochloride Contamination with burkholderia If you have questions May Class II 00536185085, 00536185097 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Diphenhydramine hydrochloride Contamination with burkholderia If you have questions May Class II 00536077085, 00536077097 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Guaifenesin & dextromethorphan Contamination with burkholderia If you have questions May Class II hydrobromide about this recall, Torrent 2019 00536097085, 00536097097 Pharma Inc 1-800-912- 9561

Guaifenesin Contamination with burkholderia If you have questions May Class II 00536082585, 00536082597 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Acetaminophen Contamination with burkholderia If you have questions May Class II 00536012285, 00536012297 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Phenobarbital Contamination with burkholderia If you have questions May Class II 16571033016 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Guaifenesin, Codeine Phosphate Contamination with burkholderia If you have questions May Class II & Pseudoephedrine about this recall, Torrent 2019 Hydrochloride Pharma Inc 1-800-912- 16571030116 9561

Guaifenesin AC Contamination with burkholderia If you have questions May Class II 16571030216 about this recall, Torrent 2019

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharma Inc 1-800-912- 9561

Acetic Acid Contamination with burkholderia If you have questions May Class II 64980042415 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Hyoscyamine sulfate Contamination with burkholderia If you have questions May Class II 39328004715, 39328004816 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Cyproheptadine hydrochloride Contamination with burkholderia If you have questions May Class II 39328004416 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Bisacodyl Contamination with burkholderia If you have questions May Class II 00904505812, 00904505860 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Pedia Relief Contamination with burkholderia If you have questions May Class II 00904505020 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Robafen dm cough sugar free Contamination with burkholderia If you have questions May Class II clear about this recall, Torrent 2019 00904630620 Pharma Inc 1-800-912- 9561

Oxymetazoline Hydrochloride Contamination with burkholderia If you have questions May Class II 00904571130, 00904571135 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Pseudoephedrine hydrochloride Contamination with burkholderia If you have questions May Class II 00536185085, 00536185097 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Banofen Contamination with burkholderia If you have questions May Class II 904517416 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Robafen DM Contamination with burkholderia If you have questions May Class II 00904005300, 00904005316 about this recall, Torrent 2019 00904005309 Pharma Inc 1-800-912- 9561

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Robafen AC Contamination with burkholderia If you have questions May Class II 00904647916 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Risperidone Contamination with burkholderia If you have questions May Class II 13668058906 about this recall, Torrent 2019 Pharma Inc 1-800-912- 9561

Pecgen dmx Incorrect labeling instructions If you have questions May Class I 52083063016 about this recall, Novis PR 2019 1-800-727-6711

Cefdinir for oral suspension Metal piece identified in the product If you have questions May Class II 68180072310, 68180072320 bottle about this recall, Lupin 2019 Pharmaceuticals Inc 1- 410-576-2000

Articaine Hydrochloride and Mislabeling If you have questions May Class II Epinephrine Bitartrate® about this recall, 2019 66312060116 Septodont Inc 1-717-286- 0100

Losartan Potassium tablets Presence of an impurity If you have questions May Class II 23155064503, 23155064509, about this recall, Heritage 2019 23155064510, 23155064603, 23155064610, 23155064609,

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

23155064403, 23155064410, Pharmaceuticals Inc 1- 23155064409 866-901-DRUG (3784)

Amitiza® 24 mcg capsules were found in a 8 If you have questions May Class II 64764008060, 64764024010, mcg about this recall, 2019 64764024060 Mallinckrodt Pharmaceuticals 1-314- 654-2000

Losartan Potassium tablets Presence of an impurity If you have questions May Class II 60429031610, 60429031690, about this recall, Golden 2019 60429031630, 60429031810, State Medical Supply Inc 60429031890, 60429031830 1-800-284-8633 ext. 215

Divalproex sodium Exposed above 50% relative humidity If you have questions April Class II 00904636345, 00904636361 levels about this recall, Major 2019 Pharmaceuticals 1-800- 875-0123 option 5

Losartan Potassium tab Presence of an impurity If you have questions April Class II 68788004809 about this recall, Preferred 2019 Pharmaceuticals Inc 1- 714-777-3729

Carvedilol tablets Label Mix-up If you have questions April Class II 65841061605 about this recall, Zydus 2019

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pharmaceuticals 1-877- 993-8779

Ketorolac tromethamine Lack of sterility If you have questions April Class II 25021070101, 25021070102 about this recall, Sagent 2019 Pharmaceuticals 1-866- 625-1618

Acyclovir tablets Label mix-up If you have questions April Class II 68382079101, 68382079106, about this recall, Zydus 2019 68382079116, 68382079105, Pharmaceuticals 1-877- 68382079110, 68382079130 993-8779

Fentanyl transdermal system, 12 Label mix-up If you have questions April Class I mcg/h about this recall, Alvogen 2019 47781042347 1-866-770-3024

Losartan Potassium/hctz Presence of an impurity If you have questions April Class II 70518156000 about this recall, Remedy 2019 Repack 1-866-845-3791

Losartan Potassium and Presence of an impurity If you have questions April Class II hydrochlorothiazide tablets about this recall, Torrent 2019 13668011610, 13668011674, Pharmaceuticals 1-800- 13668011630, 13668011690, 912-9561 13668011710, 13668011774, 13668011730, 13668011790,

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

13668011810, 13668011874, 13668011830, 13668011890 Losartan Potassium Presence of an impurity If you have questions April Class II 68645049454 about this recall, Legacy 2019 Pharmaceutical Packaging LLC 1-314-813-1555

Losartan Potassium Presence of an impurity If you have questions April Class !! 50268051715, 50268051615 about this recall, Avkare 2019 Inc 1-931-292-6222

Losartan Potassium Presence of an impurity If you have questions April Class II 13668011310, 13668011390, about this recall, Torrent 2019 13668011374, 13668040990, Pharmaceuticals 1-800- 13668040930, 13668040910, 912-9561 13668040974, 13668011510, 13668011574, 13668011530, 13668011590

Gavilyte- N Labeling incorrectly classified If you have questions March Class II 43386-0050-19 about this recall, Lupin 2019 Pharmaceuticals 1-800- 399-2561

Combigan Trace amounts of an impurity If you have questions March Class II 00023921103, 00023921110, about this recall, Ecolab 1- 2019 00023921105, 00023921115 800-433-8871

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pravastatin Sodium Foreign tablet in bottle If you have questions March Class II 68462-0196-05, 68462-0196-90 about this recall, Glenmark 2019 Pharmaceuticals, Inc. 201- 684-8000

Losartan Trace amounts of impurity If you have questions March Class II 70518-0588-01 about this recall, Remedy 2019 repack Inc 1-886-845- 3791

Phenobarbital The label contains the incorrect If you have questions March Class II 70166-0536-02 expiration date about this recall, Lohxa 2019 LLC 1-800-641-5564

Losartan Potassium Impurity found If you have questions March Class II 31722-0702-30 about this recall, Pharma 2019 Pac 1-805-929-1333

Volumex Lack of assurance If you have questions March Class II 50914-7720-08 about this recall, Iso-Tex 2019 Diagnostics 1-800-477- 4539

Hydrocortisone and Acetic Acid Sub Potent Drug If you have questions March Class II 50383-0301-10 about this recall, call Akon 2019 Inc. 1-800-477-4539

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Losartan Potassium Trace amounts of impurity If you have questions February Class II 68645-0578-54 about this recall, Call 2019 Legacy 1-877-538-8443

Losartan Presence of Impurity If you have questions February Class II Potassium/Hydrochlorothiazide about this recall, Call 2019 13668-0118-10, 13668-0118-74, Torrent Pharmaceuticals 13668-0118-30,13668-0118-90, 1-800-912-9561 13668-0117-10, 13668-0117-74, 13668-0117-30, 13668-0117-90, 13668-0116-10, 13668-0116-74, 13668-0116-30, 13668-0116-90 Losartan Potassium Presence of an impurity If you have questions February Class II 13668-0113-10, 13668-0113-90, about this recall, Call 2019 13668-0113-74, 13668-0409-10, Torrent Pharmaceuticals 13668-0409-74, 13668-0409-30, 1-800-912-9561 13668-0409-90, 13668-0115-10, 13668-0115-74, 13668-0115-30, 13668-0115-90 Valsartan Presence of an impurity If you have questions February Class II 52343-0122-30, 52343-0123-90, about this recall, Call 2019 52343-0124-90, 52343-0125-90 Preferred Pharmaceuticals 1-855-544-9419

Losartan Potassium Presence of an impurity If you have questions February Class II 68788-6882-03, 68788-6882-09 about this recall, Call 2019

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Preferred Pharmaceuticals 1-855-544-9419

Valsartan Trace amounts of an impurity If you have questions February Class II 60687-0139-01 about this recall, call 2019 Aurobindo 1-800-912- 9572

Losartan Potassium Trace amounts of an impurity If you have questions February Class II 31722-0702-05, 31722-0702-30, about this recall, call 2019 31722-0702-90, 31722-0702-10, Aurobindo 1-800-912- 31722-0702-60, 50268-0517-15, 9572 50268-0513-15, 50268-0514-15, 68645-0577-54 Alprazolam Failed impurities/degradation If you have questions January Class II 51079-0788-20 about this recall, call Mylan 2019 1-888-406-9305

Ceftriaxone for Injection Presence of Particulate Matter: If you have questions January Class I 68180-0611-01 Product complaints received of grey about this recall, Lupin 2019 flecks, identified as shredded rubber Pharmaceuticals Inc. particulate matter from the stopper 111 S Calvert St Fl 21ST observed in reconstituted vials Baltimore, MD 21202-6174

Vecuronium Bromide for Injection Presence of Particulate Matter: If you have questions January Class I 10 mg Foreign matter identified as glass about this recall, Sun 2019 47335-0931-44 detected in Vecuronium Bromide for Pharmaceutical Industries, Injection. Inc.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

270 Prospect Plains Rd Cranbury, NJ 08512-3605

OZURDEX Deviations: A silicone particulate was If you have questions January Class II 0023-3348-07 noted in Ozurdex about this recall, Allergan, 2019 PLC. 5 Giralda Farms Madison, NJ 07940-1027 (714) 246-4500

Estradiol Vaginal Inserts 68462- Defective Delivery System: Customer If you have questions January Class II 711-71 complaints of malfunctioning plunger about this recall, Glenmark 2019 68462-711-88 of the applicator Pharmaceuticals Inc., USA 750 Corporate Dr Mahwah, NJ 07430-2009

Dianeal Low Calcium Lack of Assurance of Sterility: If you have questions January Class II 00941-0424-52 Confirmed customer complaints for about this recall, Baxter 2019 Lot #: Y281477 leaks on the tubing Healthcare Corporation Expiration: 02/2020 1 Baxter Pkwy Deerfield, IL 60015-4625

Cefdinir for Oral Suspension Deviations: Product complaints If you have questions January Class II USP received indicating reconstituted about this recall, Lupin 2019 125mg/5mL suspension was observed to be thick Pharmaceuticals Inc. 68180-0722-10 111 S Calvert St Fl 21ST 68180-0722-20 Baltimore, MD 21202- 6174

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

866-587-4617 Cidofovir Injection 375mg Lack of Assurance of Sterility: If you have questions January Class II 23255-0216-31 complaints received about dried about this recall, Heritage 2019 powder on the outside of bottle Pharmaceuticals, Inc. 1 Tower Center Blvd Ste 1700 East Brunswick, NJ 08816-1145 732) 429-1000

Cephalexin for Oral Suspension Deviation; manufacturing batch record If you have questions January Class II USP could not be located about this recall, Lupin 2019 68180-0124-01 Pharmaceuticals Inc. 68180-0124-02 111 S Calvert St Fl 21ST Baltimore, MD 21202

866-587-4617

Valsartan tablets USP 320 mg Deviations: FDA lab confirmed If you have questions January Class II 65862-0573-05 presence an impurity, N- about this recall, 2019 65862-0573-90 nitrosodimethylamine (NDEA) Aurobindo Pharma USA contained in the API used to Inc. manufacture the product above the 279 Princeton Hightstown interim acceptable daily intake level of Rd 0.083 parts per million. East Windsor, NJ 08520- 1401

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

732-839-9400

Valsartan and Deviations: FDA lab confirmed If you have questions January Class II Hydrochlorothiazide tablets presence an impurity, N- about this recall, 2019 65862-0549-10 nitrosodimethylamine (NDEA) Aurobindo Pharma USA 65862-0549-90 contained in the API used to Inc. 65862-0549-99 manufacture the product above the 279 Princeton Hightstown interim acceptable daily intake level Rd of 0.083 parts per million East Windsor, NJ 08520

732- 839-9400

Amlodipine and Valsartan Deviations: FDA lab confirmed If you have questions January Class II Tablets USP 10 mg/320 mg presence an impurity, N- about this recall, 2019 65862-0740-03 nitrosodimethylamine (NDEA) Aurobindo Pharma USA 65862-0740-30 contained in the API used to Inc. 65862-0740-90 manufacture the product above the 279 Princeton Hightstown interim acceptable daily intake level of Rd 0.083 parts per million. East Windsor, NJ 08520- 1401

732 839 9400

EEMT (esterified estrogens and The combination of esterified If you have questions January Class II methyltestosterone estrogens and methyltestosterone is about this recall, Syntho 2019 15310-0010-01 used to treat symptoms of Pharmaceuticals, Inc. menopause such as hot flashes, and 230 Sherwood Ave

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

vaginal dryness, burning, and Farmingdale, NY 11735- irritation. 1718

631-755-9898

Olmesartan Medoxomil and Failed dissolution specifications If you have questions January Class II Hydrochlorothiazide Tablets, 40 about this recall, Teva 2019 mg/25 mg Pharmaceuticals USA 00093761756 1090 Horsham Rd 00093761798 North Wales, PA 19454- 1505

888-TEVA-USA (888-838- 2872)

Fluocinolone Acetonide Topical Failed Impurities/Degradation If you have questions January Class II Solution, USP, 0.01 %, 60 mL Specifications: Expansion of October about this recall, Contact: 2019 bottle 2018 recall due to elevated out of LUPIN SOMERSET specification results for total impurities 400 Campus Dr Lot #: S700214, Exp Apr-19; that have been chemically identified Somerset, NJ 08873-1145 S700447, Exp Jun-19; S700787, as oxidative degradation products of Exp Oct-19; S701057, Exp Nov- the fluocinolone active 19; S800107, Exp Feb-20; pharmaceutical ingredient S800266, Exp Mar-20; S800524, Exp May-20; S800791 Kul Exp Jul-20

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ezetimibe and Simvastatin Presence of Foreign Substance: If you have questions January Class II Tablets 10mg/80 mg, 1000-count Product complaint of black speckles about this recall, Contact: 2019 bottles observed on tablets. Dr. Reddy's Laboratories, Inc. Lot #: 43E021 and 43E023, Exp. 107 College Rd E 01/2020 Princeton, NJ 08540-6623

Losartan potassium and This product is being recalled due to theIf you have questions November Class I hydrochlorothiazide presence of an impurity, N- about this recall, Contact 2018 1000mg/25mg tablets nitrosodiethylamine. NDEA occurs Sandoz Inc. at 1-800-525- naturally in manufacturing processes 8747 Monday-Friday 8:30 ONLY Lot: JB8912 and could cause cancer based on AM – 5:00 PM (EST) or laboratory test results. No adverse email effects related to this recall have been usdrugsafety.operations@ reported to date. novartis.com.

Montelukast Sodium 10Mg This medicine is made by Camber If you have questions September Class I Pharmaceuticals, Inc. This medicine about this recall, call 2018 is being recalled Camber Pharmaceuticals because sealed bottles labeled as Med Line at 1-866-495- Montelukast sodium tablets, 10 mg, 1995 30-count bottle from Camber were found to instead contain 90 tablets of losartan potassium tablets, 50 mg. This could result in a life-threatening condition. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Diphenoxylate Hydrochloride and This medication is made by If you have questions January Class I Atropine Sulfate tablets, 2.5 Greenstone LLC, a wholly owned about this recall, please 2018 mg/0.025 mg (Lomotil). subsidiary of Pfizer, Inc. This contact Pfizer Customer medication is being recalled due to Support at 800-879-3477. super potency. The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression are improbable.

EpiPen and EpiPen Jr Auto- This medication is made by Mylan. If you have questions May 2017 Class I Injector This medication is being recalled due about this recall, please to failure to activate the device or contact your physician, increased force needed to activate pharmacy or Mylan due to a potential defect in a supplier Customer Relations at component. The potential defect 800-796-9526 or could make the device difficult to customer.service@mylan. activate in an emergency. This could com. result in a life-threatening condition.

NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information.