PHARMACY TIMES BY IEHP PHARMACEUTICAL SERVICES DEPARTMENT April 06, 2020 URGENT: Recalls, Market Withdrawals, & Safety Alerts
Dear IEHP Providers,
According to the FDA recall guidance, Title 21 Code of Federal Regulations Part 7 (21 CFR part 7), recalled products must be promptly removed or corrected. In an effort to promote health and wellness of our members, please review your records and notify members who may have been impacted by these recalls and market withdrawals.
Product Name Product Code Lot # and Exp. Date Classification Recalling Firm Phenytoin 125 mg/5 mL NDC: 51672-4069-01 327874, 327876 Exp. Class I Taro Oral Suspension 12/2020 Pharmaceuticals U.S.A., Inc. All Montelukast generics Not Provided Not Provided Safety Alert Not Applicable Ketorolac Tromethamine NDC: 00641-6042-25 038366 03/2020; MW Hikma 30mg/ml Injection 048365, 048367 Exp. Pharmaceuticals 04/2020; USA Inc. 078301, 078303 Exp. 07/2020; 118358 Exp. 11/2020; 019413 Exp. 01/2021; 029353 Exp. 02/2021 Alprostadil/Papaverine NDC: 71283-0547-02 12042019+533247, Exp. Class II Fusion IV Hydrochloride/Phentolami 1/17/2020 Pharmaceuticals, ne Mesylate/Atropine Inc. dba Axia Sulfate 18 Pharmaceutical mcg/1.8mg/0.2mg/0.02mg /mL Intracavernosal Injection Alprostadil/Papaverine NDC: 71283-0549-02 12042019+533225, Exp. Class II Fusion IV Hydrochloride/Phentolami 1/17/2020 Pharmaceuticals, ne Mesylate/Atropine Inc. dba Axia Sulfate 40 mcg/25 Pharmaceutical mg/0.5mg/0.01mg/ml Intracavernosal Injection Alprostadil/Papaverine NDC: 71283-0550-02 12042019+53323, Exp. Class II Fusion IV Hydrochloride/Phentolamine Mesylate/Atropine Sulfate 60 1/17/2020 Pharmaceuticals, mcg/30 mg/2 mg/0.15mg/ml Inc. dba Axia Intracavernosal Injection Pharmaceutical 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Alprostadil (prostaglandin NDC: 71283-0538-02 12042019+53331, Exp. Class II Fusion IV E1)150 mcg/ml 1/17/2020 Pharmaceuticals, Intracavernosal Injection Inc. dba Axia Pharmaceutical Alprostadil (prostaglandin NDC: 71283-0543-02 11112019+53208, Exp. Class II Fusion IV E1) 80 mcg/ml 4/29/2020 Pharmaceuticals, Intracavernosal Injection Inc. dba Axia Pharmaceutical Alprostadil/Papaverine NDC: 71283-0545-02 11112019+53210, Exp. Class II Fusion IV Hydrochloride/Phentolami 4/4/2020 Pharmaceuticals, ne Mesylate Injection Inc. dba Axia 20mcg/30MG/1MG/ml Pharmaceutical Intracavernosal Injection Alprostadil/Papaverine NDC: 71283-0546-02 11112019+53214, Exp. Class II Fusion IV Hydrochloride/Phentolami 3/5/2020 Pharmaceuticals, ne Mesylate Injection Inc. dba Axia 40mcg/30MG/2MG/ml Pharmaceutical Intracavernosal Injection AscorbiX (Buffered C) NDC: 71283-0226-03 07112019+52635, Exp. Class II Fusion IV Injection, Ascorbix (30ml) 1/17/2020; Pharmaceuticals, 500MG/ml Injectable 09092019+52890, Exp. Inc. dba Axia 3/17/2020 Pharmaceutical AscorbiX (Buffered C) NDC: 71283-0226-05 08222019+52828, Exp. Class II Fusion IV Injection, Ascorbix (50ml) 2/28/2020; Pharmaceuticals, 500MG/ml Injectable 09092019+52889, Exp. Inc. dba Axia 3/17/2020; Pharmaceutical 09182019+52924, Exp. 3/26/2020; 09262019+52971, Exp. 4/3/2020; 10142019+53108, Exp. 4/21/2020; 10212019+53136, Exp. 4/28/2020; 10302019+53164, Exp. 5/7/2020; 11252019+53278, Exp. 6/2/2020; 11262019+53284, Exp. 6/3/2020 B-Complex 110 Injectable NDC: 71283-0212-03 07022019+52584, Class II Fusion IV 07022019+52579, Exp. Pharmaceuticals, 3/29/2020; 08012019+52780, 08012019+52782, Exp. Inc. dba Axia 4/28/2020; 11262019+53288, Pharmaceutical Exp. 8/23/2020
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Betamethasone NDC: 71283-0620-02 10022019+53004, Exp. Class II Fusion IV Acetate/Betamethasone 2/28/2020; Pharmaceuticals, (Preservative free) 11252019+53282, Exp. Inc. dba Axia Injectable Suspension, 6/12/2020 Pharmaceutical Betamethasone Acetate/Betamethasone (Preservative free) CMC [2ml] 6mg/ml Injectable Suspension Betamethasone NDC: 71283-0621-01 07092019+52610, Exp. Class II Fusion IV Acetate/Betamethasone 2/6/2020; Pharmaceuticals, (Preservative free) 07232019+52734, Exp. Inc. dba Axia Injectable Suspension, 2/19/2020; Pharmaceutical Betamethasone 08282019+52853, Acetate/Betamethasone 09042019+52878, (Preservative free) CMC 09102019+52903, Exp. [10ml] 7mg/ml Injectable 3/2/2020; Suspension 09182019+52929, Exp. 4/17/2020; 10092019+53082, Exp. 2/28/2020, 10152019+53124; Exp. 5/4/2020; 10222019+53142, Exp. 2/28/2020; 10292019+53160, 11052019+53186, Exp. 5/4/2020; 11202019+53257, Exp. 6/19/2020; 11212019+53270, Exp. 6/20/2020; 12042019+53317, Exp. 7/3/2020; 12102019+53363, Exp. 7/9/2020 Betamethasone NDC: 71283-0621-05 07232019+52738, Exp. Class II Fusion IV Acetate/Betamethasone 2/20/2020 Pharmaceuticals, (Preservative free) Inc. dba Axia Injectable Suspension, Pharmaceutical Betamethasone Acetate/Betamethasone (Preservative free) CMC [5ml] 7mg/ml Injectable Suspension
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Biotin (Vitamin H) NDC: 71283-0220-03 11132019+53229, Exp. Class II Fusion IV Injectable Suspension, 2/10/2020 Pharmaceuticals, Biotin 10 mg/ml Injection Inc. dba Axia Suspension Pharmaceutical Calcium Chloride Injection NDC: 71283-0225-03 10302019+53166, Exp. Class II Fusion IV 2/15/2020 Pharmaceuticals, Inc. dba Axia Pharmaceutical Coenzyme Q10 Injection, NDC: 71283-0411-01 06032019+52353, Exp. Class II Fusion IV Coenzyme Q-10 20 mg/ml 7/29/2020; Pharmaceuticals, Oil Injection Solution 07082019+52596, Exp. Inc. dba Axia 9/2/2020; Pharmaceutical 10012019+52986, Exp. 8/12/2020; 12122019+53374, Exp. 1/25/2021 Cyanocobalamin Injection, NDC: 71283-0330-03 Lot #:07172019+52695, Class II Fusion IV Cyanocobalamin 2000 07172019+52697, Pharmaceuticals, mcg/ml Injectable 07252019+52759, Exp. Inc. dba Axia 1/25/2020 Pharmaceutical Cyanocobalamin/Folinic NDC: 71283-0333-03 09252019+52967, Exp. Class II Fusion IV Acid Injection, 4/4/2020 Pharmaceuticals, Cyanocobalamin : Folinic Inc. dba Axia Acid 2000 mcg/ml: 500 Pharmaceutical mcg/ml Injectable Deoxycholic Acid Sodium NDC: 71283-0462-03 10082019+53080, Exp. Class II Fusion IV Injection, Deoxycholic Acid 6/30/2020; Pharmaceuticals, Sodium 1.67% Injectable 11192019+53251, Exp. Inc. dba Axia 8/24/2020 Pharmaceutical Dexamethasone (La) NDC: 71283-0630-01 10022019+53002, Exp. Class II Fusion IV Injectable Suspension, 10/1/2020 Pharmaceuticals, Dexamethasone La [10ml] Inc. dba Axia 16mg Injection Suspension Pharmaceutical Dexpanthenol Injection, NDC: 71283-0214-03 07242019+52740, Exp. Class II Fusion IV Dexpanthenol 250 mg/ml 1/20/2020; Pharmaceuticals, injectable 11202019+53259, Exp. Inc. dba Axia 5/18/2020 Pharmaceutical Glutathione Injection, NDC: 71283-1231-03 10212019+53138, Exp. Class II Fusion IV Glutathione 200 mg/ml 11/19/2020; Pharmaceuticals, Injectable 10302019+53172, Exp. Inc. dba Axia 1/28/2020; Pharmaceutical 11122019+53225, Exp. 2/10/2020
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Glycerin (Preservative free) NDC: 71283-0464-01 08142019+52805, Exp. Class II Fusion IV Injection, Glycerin 99% 2/10/2020 Pharmaceuticals, Injectable Inc. dba Axia Pharmaceutical Glycine Injection, Glycine NDC: 71283-0344-03 07012019+52572, Exp. Class II Fusion IV 50 mg/ml Injectable 4/6/2020; Pharmaceuticals, 10102019+53106, Exp. Inc. dba Axia 6/30/2020 Pharmaceutical Human Chorionic NDC: 71283-0533-01 07222019+52720, Exp. Class II Fusion IV Gonadotropin (HCG) 1/28/2020; Pharmaceuticals, Injection, HCG [10ml] 1000 09182019+52923, Exp. Inc. dba Axia IU/ml Injectable 3/26/2020; Pharmaceutical 10232019+53148, Exp. 2/28/2020; 11142019+53243, Exp. 5/22/2020 Hydroxocobalamin NDC: 71283-0339-03 11042019+53179, Exp. Class II Fusion IV Injection, 2/18/2020 Pharmaceuticals, Hydroxocobalamin 5 Inc. dba Axia mg/ml Injectable Pharmaceutical Hydroxyprogesterone NDC: 71283-0532-05 07302019+52772, Exp. Class II Fusion IV Caproate Injection, 2/25/2020 Pharmaceuticals, Hydroxyprogesterone Inc. dba Axia Caproate [4ml] 250 mg/ml Pharmaceutical Injectable Arginine Hydrochloride NDC: 71283-0341-03 10242019+53154, Exp. Class II Fusion IV Injection, L-Arginine HCl 1/22/2020 Pharmaceuticals, 100 mg/ml Injectable Inc. dba Axia Pharmaceutical Polyoxyl Lauryl Ether NDC: 71283-060-03 10152019+53126, Exp. Class II Fusion IV (Polidocanol) Injection, 4/6/2020 Pharmaceuticals, Laureth-9 (Polidocanol) 5% Inc. dba Axia Injectable Pharmaceutical Levocarnitine Injection, NDC: 71283-9260-03 08212019+52824, Exp. Class II Fusion IV Levocarnitine 500 mg/ml 2/17/2020 Pharmaceuticals, Injectable Inc. dba Axia Pharmaceutical Lidocaine HCl (Preservative NDC: 71283-1011-05 07012019+52569, Exp. Class II Fusion IV free) Injection, Lidocaine 3/15/2020 Pharmaceuticals, HCl 4% (Preservative free) Inc. dba Axia 40 mg/ml Ocular injection Pharmaceutical Lysine Hydrochloride NDC: 71283-0342-03 10222019+53144, Exp. Class II Fusion IV Injection, Lysine HCl 100 1/27/2020 Pharmaceuticals, mg/ml Injectable Inc. dba Axia Pharmaceutical 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Methionine/Inositol/Cholin NDC: 71283-0215-03 09052019+52881, Exp. Class II Fusion IV e Injection, 4/7/2020; Pharmaceuticals, Methionine/Inositol/Cholin 09302019+52977, Exp. Inc. dba Axia e 25mg/50mg/50mg/ml 5/2/2020; Pharmaceutical Injectable 10072019+53049, Exp. 5/9/2020 Methylcobalamin Injection, NDC: 71283-0338-03 07292019+52764, Exp. Class II Fusion IV Methylcobalamin [CD] 1/25/2020; Pharmaceuticals, 10mg/100mg/ml Injectable 07292019+52766, Exp. Inc. dba Axia 1/25/2020 Pharmaceutical Methylcobalamin Injection, NDC: 71283-0331-03 07232019+52730, Exp. Class II Fusion IV Methylcobalamin 1 mg/ml 1/19/2020; Pharmaceuticals, Injectable 07232019+52732, Exp. Inc. dba Axia 1/19/2020; Pharmaceutical 07242019+52748, Exp. 1/20/2020; 11212019+53272, Exp. 5/19/2020 Methylprednisolone NDC: 71283-0623-01 09042019+52874, Exp. Class II Fusion IV Acetate/Bupivacaine 3/2/2020 Pharmaceuticals, Hydrochloride Injectable Inc. dba Axia Suspension, Pharmaceutical Methylprednisolone Acetate/Bupivacaine [10ml] CMC 40mg/5mg/ml Injection Suspension Methylprednisolone NDC: 71283-0624-01 09042019+52876, Exp. Class II Fusion IV Acetate/Bupivacaine 3/2/2020 Pharmaceuticals, Hydrochloride Injectable Inc. dba Axia Suspension, Pharmaceutical Methylprednisolone Acetate/Bupivacaine [10ml] CMC 80mg/5mg/ml Injection Suspension Methylprednisolone NDC: 71283-0639-02 06102019+52398, Exp. Class II Fusion IV Acetate Injectable 2/24/2020 Pharmaceuticals, Suspension, Inc. dba Axia Methylprednisolone Pharmaceutical Acetate (Preservative free) CMC [2ml] 80 mg/ml Injection Suspension Methylprednisolone Acetate NDC: 71283-0619-01 06122019+52423, Exp. Class II Fusion IV Injectable Suspension, 7/9/2020; 06122019+52420, Pharmaceuticals, Methylprednisolone Acetate Exp. 7/9/2020; [10ml] CMC 100 mg/ml Injection 07182019+52703, Exp. Inc. dba Axia Suspension 8/14/2020 Pharmaceutical 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Methylprednisolone NDC: 71283-0636-01 03202019+51817, Exp. Class II Fusion IV Acetate Injectable 4/16/2020; Pharmaceuticals, Suspension, 09122019+52911, Exp. Inc. dba Axia Methylprednisolone 10/9/2020; Pharmaceutical Acetate [10ml] CMC 50 09132019+52918, Exp. mg/ml Injection Suspension 8/12/2020 MIC-B12 Injection, MIC-B12 NDC: 71283-0230-03 07102019+52618, Exp. Class II Fusion IV 25mg/50mg/50mg/1mg/ml 2/8/2020; Pharmaceuticals, Injectable 09052019+52880, Exp. Inc. dba Axia 4/5/2020; Pharmaceutical 10012019+52983, Exp. 5/1/2020; 11052019+53188, Exp. 6/5/2020; 12112019+53367, Exp. 7/11/2020 MIC-PLEX Injection, NDC: 71283-0233-03 11212019+53263, Exp. Class II Fusion IV Vitamin Complex, MIC- 2/16/2020; Pharmaceuticals, COMBO* 11252019+53276, Exp. Inc. dba Axia 25MG/50MG/50MG/1MG/ 2/20/2020 Pharmaceutical 20MG/5MG/ml Injectable MIC-PLUS Injection, NDC: 71283-0231-03 06242019+52513, Exp. Class II Fusion IV Vitamin Complex, MIC- 1/23/2020; Pharmaceuticals, COMBO* 06242019+52515, Exp. Inc. dba Axia 25MG/50MG/50MG/1MG/ 1/23/2020; Pharmaceutical 20MG/5MG/ml Injectable 07252019+52756, Exp. 2/23/2020; 08212019+52823, Exp. 3/21/2020; 10012019+52989, Exp. 5/1/2020; 11062019+53194, Exp. 6/6/2020 Mitomycin-C (Preservative NDC: 71283-0812-08 07082019+52606, Exp. Class II Fusion IV free) Irrigation Solution, 4/3/2020; Pharmaceuticals, MITOMYCIN-C 07242019+52742, Exp. Inc. dba Axia (Preservative free) 0.5 7/22/2020; Pharmaceutical MG/ml Preservative Free 07242019+52745, Exp. Syringe, For Intravesicular 7/22/2020; 09112019+52907, Exp. 5/31/2020; 11142019+53235, Exp. 11/12/2020 Nicotinamide Adenine NDC: 71283-0306-01 08282019+52850, Exp. Class II Fusion IV Dinucleotide (Preservative 1/24/2020; Pharmaceuticals,
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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free) Injection, 10102019+53094, Exp. Inc. dba Axia Nicotinamide Adenine 2/28/2020; Pharmaceutical Dinucleotide (Preservative 10312019+53174, Exp. free) 50 mg/ml Injectable 3/28/2020 Nicotinamide Adenine NDC: 71283-0336-01 10082019+53069, Exp. Class II Fusion IV Dinucleotide (Preservative 2/28/2020 Pharmaceuticals, free) Injection, Inc. dba Axia Nicotinamide Adenine Pharmaceutical Dinucleotide (Preservative free) 20 mg/ml Injectable Iohexol (Preservative free) NDC: 71283-1413-05 10012019+52984, Exp. Class II Fusion IV Injection, Omnipaque 1/19/2020 Pharmaceuticals, Injection [5ml] 300 mg/ml Inc. dba Axia Injectable Pharmaceutical Pyridoxine Hydrochloride NDC: 71283-0216-03 09132019+52914, Exp. Class II Fusion IV Injection, Pyridoxine HCl 2/28/2020; Pharmaceuticals, 100 MG/ml Injectable 09162019+52920, Exp. Inc. dba Axia 3/2/2020; Pharmaceutical 09192019+52939; Exp. 2/28/2020; 10292019+53162, Exp. 4/14/2020; 12112019+53369, Exp. 5/27/2020 Selenium Injection, NDC: 71283-0227-03 11052019+53182, Exp. Class II Fusion IV Selenium 200 mcg/ml 4/7/2020 Pharmaceuticals, Injectable Inc. dba Axia Pharmaceutical Super MIC Injection, Super NDC: 71283-0234-03 11042019+53181, Exp. Class II Fusion IV MIC* Injectable, Vitamin 2/2/2020; Pharmaceuticals, Complex 12122019+53376, Exp. Inc. dba Axia 3/11/2020 Pharmaceutical Testosterone Cypionate NDC: 71283-0530-01 03252019+51850, Exp. 7/6/2020; Class II Fusion IV 04252019+52098, Exp. 6/29/2020; Injection, Testosterone 04292019+52108, Exp. 6/29/2020; Pharmaceuticals, Cypionate in grapeseed oil 05012019+52132, Exp. 10/22/2020; Inc. dba Axia 05202019+52268, Exp. 11/10/2020; [10 ml] 200 MG/ml 05222019+52290, Exp. 11/10/2020; Pharmaceutical Injectable 05302019+52334, Exp. 11/20/2020; 07082019+52594, Exp. 12/29/2020; 07102019+52619, Exp. 12/29/2020; 07292019+52762, Exp. 8/12/2020; 07312019+52778, Exp. 8/12/2020; 09102019+52898, Exp. 1/16/2021; 09112019+52905, Exp. 1/18/2021 Testosterone Cypionate NDC: 71283-0530-02 03062019+51706, Exp. Class II Fusion IV Injection, Testosterone 6/28/2020 Pharmaceuticals, Cypionate in grapeseed oil Inc. dba Axia Pharmaceutical
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
[1 ml] 200 MG/ml Injectable Testosterone NDC: 71283-0531-02 03042019+51685, Exp. Class II Fusion IV Cypionate/Progesterone 6/26/2020 Pharmaceuticals, Injection, Testosterone Inc. dba Axia Cypionate/Progesterone Pharmaceutical [2ml] 200mg/2.5mg/ml Injectable Triamcinolone NDC: 71283-0632-01 05292019+52328, Exp. Class II Fusion IV Acetonide/Bupivacaine 2/13/2020 Pharmaceuticals, Hydrochloride Injectable Inc. dba Axia Suspension, Triamcinolone Pharmaceutical Acetonide/Bupivacaine HCl [10ml] 40mg/5mg/ml Injection Suspension Triamcinolone Acetonide NDC: 71283-0635-02 08272019+52841, Exp. Class II Fusion IV (Preservative free) 2/22/2020; Pharmaceuticals, Injectable Suspension, 09242019+52953, Exp. Inc. dba Axia Triamcinolone Acetonide 3/22/2020; Pharmaceutical (Preservative free) [2ml] 11072019+53198, Exp. 40mg/ml Injection 5/5/2020; Suspension 11112019+53206, Exp. 5/9/2020; 11122019+53223, Exp. 5/10/2020 Triamcinolone Acetonide NDC: 71283-0633-01 06132019+52446, Exp. Class II Fusion IV (Preservative free) 7/17/2020; Pharmaceuticals, Injectable Suspension, 11142019+53240, Exp. Inc. dba Axia Triamcinolone Acetonide 12/18/2020 Pharmaceutical (Preservative free) [10ml] 50 mg/ml Injection Suspension Triamcinolone Diacetate NDC: 71283-0625-01 10102019+53104, Exp. Class II Fusion IV Injectable Suspension, 5/4/2020 Pharmaceuticals, Triamcinolone Diacetate Inc. dba Axia [10ml] CMC 10 mg/ml Pharmaceutical Injection Suspension Triamcinolone Diacetate NDC: 71283-0628-02 08272019+52845, Exp. Class II Fusion IV Injectable Suspension, 2/23/2020; Pharmaceuticals, Triamcinolone Diacetate 09252019+52965, Exp. Inc. dba Axia (Preservative free) [2ml] CMC 3/23/2020 Pharmaceutical 40 mg/ml Injection Suspension Triamcinolone Diacetate NDC: 71283-0634-01 07162019+52686, Exp. Class II Fusion IV Injectable Suspension, 4/11/2020; Pharmaceuticals,
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Triamcinolone Diacetate 11062019+53192, Exp. Inc. dba Axia [10ml] CMC 80 mg/ml 8/2/2020 Pharmaceutical Injection Suspension Cholecalciferol (Vitamin NDC: 71283-0210-03 04082019+51930, Exp. Class II Fusion IV D3) Injection, Vitamin D3 4/8/2020; Pharmaceuticals, [P] 1,000 IU/ml Injectable 09092019+52891, Exp. Inc. dba Axia 8/12/2020 Pharmaceutical Cholecalciferol (Vitamin NDC: 71283-0251-03 04292019+52110, Exp. Class II Fusion IV D3) Injection, Vitamin D3 4/28/2020; Pharmaceuticals, [P] 100,000 IU/ml 06252019+52525, Exp. Inc. dba Axia Injectable 6/24/2020; Pharmaceutical 09252019+52962, 10072019+53051, Exp. 8/12/2020 Zinc Chloride Injection, Zinc NDC: 71283-0224-03 10302019+53170, Exp. Class II Fusion IV Chloride 10 mg/ml 2/9/2020 Pharmaceuticals, Injectable Inc. dba Axia Pharmaceutical Desoximetasone Topical Not Provided K800475 Exp. 05/2020; Class II Lupin Spray, 0.25%, 2.5 mg K800477 Exp. 06/2020 Pharmaceuticals desoximetasone Inc. Mesalamine 1.2 gram NDC: 00591-2245-22 1342500A Exp. 10/2020 Class II Teva Delayed-Release Tablets Pharmaceuticals USA Elelyso (taliglucerase alfa) NDC: 00069-0106-01 X14209 Exp. 02/2020; Class II Pfizer Inc. 200 units/vials AH4601 Exp. 03/2020; AH4603, X46389, X78365, AT2927, Exp. 04/2020; AH4602 Exp. 05/2020; AL8590,Exp. 10/2020
Ranitidine 150 mg/10 mL NDC: 68094-0204-62; 501290, 501326 501501 Class II Precision Dose Inc. Oral Solution 68094-0204-61; Exp. 11/30/19; 68094-0204-59 501592, 501679 Exp. 4/30/20 Ranitidine 150 mg Tablets NDC: 60687-322-01; 179516, 179745, Exp. Class II American Health 60687-0322-11 12/31/2019; Packaging 180712 Exp. 02/29/2020; 180819 exp. 04/30/2020; 181403, 182544, 183155, 183236 Exp. 05/31/2020; 185739, 186600, 186702 Exp. 12/31/2020
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
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Acetylcysteine Ophthalmic NDC Not Provided 02242020@1 Class II Redline Pharmacy 10% Solution, 5 mL per Solutions dropper bottle (10ML)
Morphine Sulfate, 20 NDC Not Provided 02242020@2 Class II Redline Pharmacy mg/mL intrathecal, 20 mL Solutions per syringe Daptomycin, 500 mg in NDC Not Provided 02242020@3, Class II Redline Pharmacy 0.9% NaCl 100 mL 02242020@9 Solutions Injectable
Ertapenem in 100 mL 0.9% NDC Not Provided 02242020@7 Class II Redline Pharmacy NaCl 1 gram Injectable, Solutions
Vancomycin 900 mg in 100 NDC Not Provided 02242020@8 Class II Redline Pharmacy mL 0.9% NaCl Injectable Solutions
Morphine Sulfate NDC Not Provided 02242020@14 Class II Redline Pharmacy (MITIGO), 5 mg/mL Solutions intrathecal, 40 mL per syringe Acetaminophen 500 mg NDC: 52959-0002-30; AE00M, Exp. 08/2021 Class II H J Harkins tablet 52959-0002-42; Company Inc dba 52959-0002-45; Pharma Pac 52959-0002-50 Lisinopril/HCTZ NDC: 68180-0519-02; Lot #: J0322819-091418, Class II RemedyRepack 20mg/12.5mg Tablet 70518-0382-03 Exp: 09/30/2019 Inc. Regular Strength Acid NDC: 69842-0293-65; 8DE1363, 8EE1558, Class II Perrigo Company Reducer, Ranitidine 75 mg 41163-0931-65; 8FE1450, 8GE1331, PLC Tablets, 30 tablets per 55319-0876-65; 8HE1221, 8KE2825, bottle 00113-0876-65; 8JE1916, 8KE2243, 37808-0876-65; 8ME2685, 9AE2785, 69256-0876-65; 9AE2786, 9DE2721, 62011-0283-1; 9CE3317, 9EE2579, 62011-0283-01; 9FE2957, 9GE2785, 00904-6715-46; 9GE3218, 9HE3577 21130-0118-65; 49348-0136-44; 11673-0876-65; 00363-1876-65
Regular Strength Acid NDC: 62011-0283-02; 8DE1367, 8EE1559, 8FE1451, Class II Perrigo Company Reducer, Ranitidine 75 mg 00904-6715-52; 8GE1340, 8HE1222, PLC 8KE2831, 8JE1917, 8KE2245 , Tablets, 60 tablets per 41250-0252-72; 8ME2724, 9AE2831, bottle 49348-0136-12; 9DE2747, 9CE3339, 9EE2636, 9FE2971, 9GE2793, 9GE3220
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Regular Strength Acid NDC: 00113-7876-27; 8CE1643, 8DE1370, Class II Perrigo Company Reducer, Ranitidine 75 mg 69842-0293-27; 8DE1768, 8EE1560, PLC Tablets, 80 tablets per 70000-0375-02; 8FE1452, 8GE1341, bottle 11673-0876-27; 8HE1223, 8KE2832, 00363-1876-27 8KE2246, 8ME2725, 9AE2835, 9CE3378, 9DE2748, 9EE2637, 9FE2976, 9GE2795, 9GE3228, 9HE3617 Regular Strength Acid NDC: 37808-0876-47; 8CE1644, 8CE1645, Class II Perrigo Company Reducer, Ranitidine 75 mg 49035-0876-47 8DE1401, 8DE1402, PLC Tablets, 150 tablets per 8DE1403, 8DE1769, bottle 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229 Regular Strength Acid NDC: 69842-0293-06 8FE1455, 8GE1343, Class II Perrigo Company Reducer, Ranitidine 75 mg 8HE1225, 8KE2834, PLC Tablets, 160 tablets per 8KE2249, 8ME2730, bottle 9AE2838, 9EE2639, 9FE2993 Maximum Strength Acid NDC: 00113-0852-51; 8CE1429, 8CE1760, Class II Perrigo Company Reducer, Ranitidine 150 mg 00363-0852-51 9BE2907, 9DE3183, PLC Tablets, 8 tablets 9EE2900, 9JE2936
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Maximum Strength Acid NDC: 46994-0852-62; 8EE1452R, 8AE1743, Class II Perrigo Company Reducer, Ranitidine 150 mg 41520-0392-02; 8BE1340, 8CE1549, PLC Tablets, 24 tablets per 59779-0540-02; 8CE1778, 8DE1128, bottle 55910-0852-02; 8DE1313, 8DE1640, 41163-0852-62; 8EE1117, 8EE1234, 49035-0608-02; 8EE1452, 8CE1314, 55301-0852-02; 8CE1315, 8DE1096, 55319-0852-02; 8DE1530, 8EE1699, 46122-0224-62; 8GE1528, 8HE1465, 00113-0852-62; 8JE2199, 8LE2172, 69256-0041-62; 8DE1721, 8EE1299, 49348-0109-04; 8FE1634, 8GE1833, 30142-0600-02; 8GE1835, 8HE1337, 00904-6716-24; 8LE2173, 8LE2380, 41250-0852-02; 9BE2888, 8JE2162, 56062-0099-02; 8KE2495, 8KE2496, 11822-0852-05; 8LE2169, 9BE2772, 10202-0852-62; 9BE2889, 9CE3771, 41190-0852-62; 9DE2854, 8LE2288, 37012-0852-62; 8LE2592, 8LE2593, 21130-116-02; 8ME3124, 8ME3125, 50594-0852-02; 9BE2773, 9BE2774, 62011-0282-01; 9DE3234, 9EE2603, 36800-0852-02; 9EE2903, 9FE2952, 11673-0023-02; 9CE3689, 9CE3690, 00363-0852-62 9EV1891, 9FV1152, 9DE2868, 9DE2869, 9EE2760, 9FV1153, 9EE2779, 9GE2879, 9HE3558, 9JE2591, 9FE3109, 9FE3110, 9GE2869, 9HE3433, 9JE2541
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Maximum Strength Acid NDC: 41520-0609-62; Lots: 8FV1462, Class II Perrigo Company Reducer, Cool Mint 59779-0950-62; 8GV1289, 8BE1465, PLC Ranitidine tablets, USP 150 55910-0423-62; 8CE1616, 8DE1277, mg, 24 tablets per bottle 41163-0950-62; 8DE1580, 8DE1766, 55319-0523-62; 8FE1348, 8GE1527, 46122-0041-62; 8GE1733, 8GE1735, 37808-0710-02; 8HE1466, 8HE1590, 30142-0891-02; 8JE2232, 8KE2676, 70000-0378-01; 8LE2283, 8LE2284, 41250-0950-02; 8LE2345, 8ME2640, 11822-0950-00; 9AE2663, 9AE2863, 37012-0950-62; 9AE2864, 9BE3158, 21130-0568-62; 9CE3773, 9CE3774, 36800-0950-62; 9CE3879, 9EE2499, 00363-0950-02NDC: 9EE2635, 9EE2904, 41520-0609-62; 9FE2821, 9FE2953, 59779-0950-62; 9FE3369, 9GE2653, 55910-0423-62; 9GE2905, 9GE3077, 41163-0950-62; 9GE3115, 9HE3546, 55319-0523-62; 9HE3559, 9JE2593 46122-0041-62; 37808-0710-02; 30142-0891-02; 70000-0378-01; 41250-0950-02; 11822-0950-00; 37012-0950-62; 21130-0568-62; 36800-0950-62; 00363-0950-02 Maximum Strength Acid NDC: 11673-0950-58 9BE3161, 9CE3880, Class II Perrigo Company Reducer, Cool Mint 9EE2500, 9FE2823, PLC Ranitidine 150 mg Tablets, 9GE2656, 9HE3554, USP , 40 tablets per bottle 9JE2676 Maximum Strength Acid NDC: 55910-0852- 8AE1744, 8BE1369, 8CE1377, Class II Perrigo Company Reducer, Ranitidine 150 mg 71; 46122-0224-71; 8CE1378, 8DE1103, PLC 8DE1531, 8EE1700, 8FV0829, Tablets, 50 tablets per 00113-0852-71; 8DE1722, 8EE1317, 8FE1635, bottle 69256-0041-71; 8GE1921, 8HE1342, 30142-0600-71; 8KE2503R, 8JE2154, 00904-6716-51; 8KE2503, 8LE2198, 8LE2597, 41250-0852-71; 9AE2499, 9BE2862, 9BE2863, 9CE3723, 9DE2890, 56062-0099-71; 9DE2891, 9EE2812, 9FE3187, 11822-0852-02; 9GE2885, 9HE3435, 9JE2656 21130-0116-71; 36800-0852-71
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Maximum Strength Acid NDC: 41520-0392-09; 8AE1752, 8BE1412, Class II Perrigo Company Reducer, Ranitidine 150 mg 59779-0540-09; 8CE1437, 8CE1439, PLC Tablets, 65 tablets per 55319-0852-09; 8DE1141, 8DE1737, bottle 46122-0532-09; 8EE1318, 8FE1690, 37808-0507-09; 8GE1928, 8HE1395, 49348-0109-54; 8JE2155, 8KE2516, 41250-0891-09; 8LE2253, 8LE2624, 11822-0852-03; 9AE2522, 9BE2933, 37012-0852-09; 9BE2934, 9CE3734, 50594-0852-09; 9DE3070, 9EE2830, 49348-0109-54; 9FE3266, 9GE2934 11673-0852-09; 00363-0852-09 Maximum Strength Acid NDC: 00113-7950-09; 8AE1884, 8BE1466, Class II Perrigo Company Reducer, Cool Mint 59779-0950-09; 8DE1318, 8CE1617, PLC Ranitidine 150 mg Tablets, 49035-0800-09; 8DE1319, 8EE1326, 65 tablets per bottle 46122-0533-09; 8DE1611, 8DE1767, 30142-0891-09; 8FE1350, 8FE1352, 36800-0950-09; 8GE1736, 8GE1840, 11673-0950-09; 8GE1859, 8HE1592, 00363-0950-09 8HE1593, 8HE1594, 8JE2234, 9CE3263, 8JE2233, 8LE2360, 8KE2704, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3124, 9GE3122, 9HE3555 Maximum Strength Acid NDC: 49035-0608-75; 8EE1702, 8EE1703, Class II Perrigo Company Reducer, Ranitidine 150 mg 11673-0023-75 8EE1704, 8FE1724, PLC Tablets, 90 tablets per 8GE1942, 8HE1396, 8HE1397, 8JE2156, bottle 8KE2521, 8KE2523, 8LE2255, 8LE2665, 8LE2668, 9AE2541, 9AE2542, 9AE2543, 9BE2993, 9BE2994, 9BE2995, 9CE3735, 9CE3736, 9DE3108, 9DE3109, 9DE3110, 9EE2872, 9EE2880, 9FE3273, 9FE3276, 9GE2978, 9GE2979, 9HE3437, 9HE3438
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Maximum Strength Acid NDC: 49035-0800-75; 8EE1514, 8EE1515, Class II Perrigo Company Reducer, Cool Mint 11673-0950-75 8FE1353, 8GE1732, PLC Ranitidine tablets, USP 150 8GE1864, 8HE1652, mg, 90 tablets per bottle 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144 Maximum Strength Acid NDC: 00113-7852-01; 8CE1446, 8DE1740, 8FE1238, Class II Perrigo Company Reducer, Ranitidine 150 mg 68391-0852-56; 8FE1794, 8GE1964, 8JE2159, PLC 8ME2546, 8ME2547, 9BE3011, Tablets, 95 tablets per 59779-0540-01; 9CE3854, 9DE3158, 9FE3340, bottle 55910-0011-01; 9HE3445, 9JE2663, 8AE1779, 63981-0852-56; 8BE1414, 8DE1199, 8DE1200, 8DE1532, 8EE1321, 8FE1239, 30142-0600-56; 8FE1346, 8FE1793, 8HE1516, 41250-0852-01; 8KE2563, 8KE2563R, 8LE2260, 11822-0852-4; 9AE2610, 9AE2612, 9BE3012, 9BE3013, 9CE3852, 9DE3156R, 00363-0852-01 9DE3160, 9DE3161, 9EE2952, 9FE3338, 9GE2993, 8AV1095, 8AV1150, 8AV1235, 8AV1236, 8AV1237, 8BV0896, 8BV0897, 8BV0910, 8BV1737, 8BV1757, 8BV1758, 8CV0930, 8CV1316, 8CV1317, 8CV1319, 8CV1324, 8CV1633, 8DV1128, 8DV1129, 8DV1134, 8EV0993, 8EV0994, 8EV0995, 8EV1240, 8FV0712, 8FV0912, 8FV0913, 8FV0914, 8FV0915, 8GV0847, 8GV0849, 8GV0997, 8HV0926, 8HV0928, 8HV1534, 8HV1535, 8JV0730, 8JV0944, 8KV2339, 8KV2348, 8KV2485, 8LV1791, 8LV2205, 8MV1650, 8MV1712, 9AV2395, 9AV2679, 9AV2680, 9BV2182, 9CV1345, 9CV1346, 9CV1347, 9CV1348, 9CV1349, 9DV1511, 9DV1515, 9EV1422, 9EV1585, 9EV1596, 9FV1132, 9FV1275R, 9FV1330, 9FV1331, 9FV1332, 9FV1333, 9FV1339, 9FV1954, 9FV1972, 9GV1675, 9GV1994, 9HV1415
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Maximum Strength Acid NDC: 0113-7950-01; 8BE1032, 8BE1486, Class II Perrigo Company Reducer, Cool Mint 59779-0950-01 8CE1638, 8DE1361, PLC Ranitidine 150 mg Tablets, 8DE1612, 8FE1354, USP , 95 tablets per bottle 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202 Maximum Strength Acid NDC: 00113-7852-82; 9CE3861, 9DE3244, Class II Perrigo Company Reducer, Ranitidine 150 mg 59779-0540-82; 9FE2820, 9FE3373, PLC Tablets, 200 tablets per 37808-0507-82; 9GE3094, 9HE3449, bottle 21130-0116-82; 9JE2665 00363-0852-82 Daytrana (methylphenidate NDC: 68968-5552-03 86280 Exp. 06/2020 Class II Noven transdermal system) Therapeutics, LLC patches, Delivers 10 mg over 9 hours (1.1 mg/hr) Daytrana (methylphenidate NDC: 68968-5553-03 85942 Exp. 03/2020; Class II Noven transdermal system) 86281 Exp. 06/2020 Therapeutics, LLC patches, Delivers 15 mg over 9 hours (1.6 mg/hr) Daytrana (methylphenidate NDC: 68968-5554-03 86081 Exp. 04/2020; Class II Noven transdermal system) 86196 Exp. 06/2020 Therapeutics, LLC patches, Delivers 20 mg over 9 hours (2.2 mg/hr) Daytrana (methylphenidate NDC: 68968-5555-03 86083 Exp. 05/2020; Class II Noven transdermal system) 86282 Exp. 06/2020 Therapeutics, LLC patches, Delivers 30 mg over 9 hours (3.3 mg/hr) Sotalol HCl 80 mg Tablets NDC: 00378-5123-01 3095754 Exp. 02/2021 Class II Mylan Pharmaceuticals Inc. Pantoprazole Sodium 40 NDC: 59746-0284-90 PA218005A Exp. Class II Jubilant Cadista mg Delayed-Release 12/2020; Pharmaceuticals, Tablets PA218P010, PA218P011, Inc. Exp. 04/2021; PA218108A, PA218110A, Exp. 06/2021 Atorvastatin Calcium 40 mg NDC: 63304-0829-05 AA33617 Exp 03/2021 Class II Sun Tablets Pharmaceutical Industries, Inc.
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity
Solifenacin Succinate 5 mg NDC: 51991-0893-33; 81244, 81217 Exp. Class II Breckenridge Tablets 51991-0893-90 01/2021; Pharmaceutical, 81245 Exp. 01/2021 Inc Solifenacin Succinate 10 mg NDC: 51991-0894-33; 81253, 81272 Exp. Class II Breckenridge Tablets 51991-0894-90 01/2021; Pharmaceutical, 81268 Exp. 01/2021 Inc Doxycycline 75 mg NDC: 63304-0615-01 AA39490 Exp. 03/2021 Class II Sun Capsules, 100-count bottle Pharmaceutical Industries, Inc. Doxycycline 100 mg NDC: 63304-0616-50 3983720 Exp 10/2020; Class II Sun Capsules, 50-count bottle 3990461, 3990464, Pharmaceutical 3990465, 3990466, Industries, Inc. 3990470 Exp 11/2020; AA42499, AA42510, AA44468, AA44470 Exp 04/2021; AA55073, AA55074, AA55075 Exp 05/2021; AA61486 Exp 06/2021 Phytonadione Injectable NDC: 43598-0405-16 ACB902, ACB903 Exp. MW Dr. Reddy’s Emulsion USP, 10 mg/mL 03/2021; Laboratories Ltd. Single-Dose Ampules ACB904 Exp. 04/2021; ACB905 Exp. 06/2021
I = Class I Recall, II = Class II Recall, MW = Market Withdrawal
Additional information can be found at: 1. FDA Recalls, Market Withdrawals, & Safety Alerts: https://www.fda.gov/Safety/Recalls/default.htm 2. FDA Enforcement Report: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm 3. IEHP Safety Resources: https://ww3.iehp.org/en/providers/pharmaceutical-services/clinical-information/safety-resources/
If you have any questions or comments regarding this recall, please call IEHP Pharmaceutical Services Department at 909-890-2049, 8am – 5pm (PST), Monday through Friday.
Sincerely,
IEHP Pharmaceutical Services
10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org
A Public Entity