PHARMACY TIMES BY IEHP PHARMACEUTICAL SERVICES DEPARTMENT July 3, 2018 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 Fluticasone Propionate Nasal Lot #NJ4501 NDC 60505-0829-01 Class II Apotex Inc. Spray 50mcg Exp. 07/20 Allergen Taytulla Softgel NDC 00023-5862-29 Lot #5620706 Exp. 05/19 Class I Allergen, PLC. Capsules 1mg/20mcg Preferred Plus Pharmacy NDC 53807-0158-12 Lot #707007, 707006, 708001 RIJ Pharmaceutical Antacid Extra Strength Class II NDC 53807-0126-12 Exp. 07/19 LLC 400mg & 200mg RIJ Pharmaceutical RPC Senna 8.8mg NDC 53807-0556-08 Lot #47070081 Exp. 09/18 Class II LLC RPC Children’s Non-Aspirin RIJ Pharmaceutical NDC 53807-0129-04 Lot #47080091 Exp. 08/19 Class II 160mg LLC Gericare Pain Relief Lot #47080081, 47080093 RIJ Pharmaceutical NDC 57896-0180-16 Class II Acetaminophen 160mg/5ml Exp. 08/19 LLC RIJ Pharmaceutical RPC APAP 160mg NDC 53807-0129-16 Lot #47080092 Exp. 08/19 Class II LLC Lot #47070082, 47070043, RIJ Pharmaceutical Gericare Senna Syrup 8.8mg NDC 57696-0452-08 Class II 47070011 Exp. 09/18 LLC Robitussin DM RIJ Pharmaceutical Dextromethorphan NDC 53807-0709-04 Lot #47070021 Exp. 07/19 Class II LLC Hydrobormide 10mg Lot #47060011, 47070031, RIJ Pharmaceutical Geritrex Senna Syrup 8.8mg NDC 54162-0007-08 47070041 Exp. 09/18 Class II LLC 47080031 Exp. 10/18 RIJ Pharmaceutical SDA Senna Syrup 8.8mg NDC 66424-0562-08 Lot #47070042 Exp. 09/18 Class II LLC Lot #47080041m 47080051 RIJ Pharmaceutical Gericare Diocto Liquid 50mg NDC 57896-0403-16 Class II Exp. 08/19 LLC Gericare Iron Supplement RIJ Pharmaceutical NDC 57896-0709-16 Lot #4780111 Exp. 08/19 Class II Elixir Ferrous Sulfate 220mg LLC MBi Distributing Inc. Teething Drops UPC 358301040110 Lot #15041402 No Exp. Date Class II dba MBi Nutraceuticals MBi Distributing Inc. Nausea Drops UPC 158301047114 Lot #17011201 No Exp. Date Class II dba MBi Nutraceuticals 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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MBi Distributing Inc. Intestinal Colic Drops No NDC/UPC Provided Lot #8040802 Exp. 04/21 Class II dba MBi Nutraceuticals MBi Distributing Inc. Stomach Calm No NDC/UPC Provided Lot #14093001 Exp. 09/20 Class II dba MBi Nutraceuticals Lot #16081901 Exp. 08/18 MBi Distributing Inc. Expectorant Cough Syrup No NDC/UPC Provided 17031604 Exp. 03/19 Class II dba MBi Nutraceuticals 17110901 Exp. 11/19 Argentum Elixir Colloidal Lot #15060201 Exp. 06/19 MBi Distributing Inc. UPC 352301181141 Class II Silver 16081704 Exp. 08/20 dba MBi Nutraceuticals MBi Distributing Inc. Silver-Zinc Throat Spray UPC 358301181189 Lot #15050801 Exp. 05/18 Class II dba MBi Nutraceuticals Shadow Holdings DBA X-Jow Pain 1.25% No NDC/UPC Provided All Lots Class II Bocchi Labs Acne Shave Post-Shave Shadow Holdings DBA UPC 780707731123 All Lots Class II Moisturizer .50% Bocchi Labs Shadow Holdings DBA Acne Shave .50% UPC 780707731116 All Lots Class II Bocchi Labs Acne Shave 3 Step Shaving Shadow Holdings DBA UPC 780707731147 All Lots Class II System .50% Bocchi Labs Ready Flush Protect Lot #18BE0005, 18BE0006 Medline Industries Inc NDC 53329-0066-58 Class II w/Dimethicone 3.2% Exp. 02/20 (Northpoint Services) Option Systems Antibacterial Lot #730201039, 730203039, No NDC/UPC Provided Class II Inopak Ltd Foaming Handwash 0.30% 730201040, 730201043 Lot #180820005D Exp. 06/18 PharMEDium Services, Hydromorphone Hcl 0.5mg No NDC/UPC Provided 180990007D Exp. 07/18 Class II LLC 181000020D Exp. 07/18 BioDiagnostic Monsel’s 20% NDC 42721-0112-08 All Lots within Expiry Class II International Dr. Reddy’s Atorvastatin Calcium 80mg NDC 55111-0124-90 Lot #T800064 Exp. 12/19 Class II Laboratories, Inc. 0.45% Sodium Chloride NDC 00409-7730-37 Lot #85-023-JT Exp. 07/19 Class II ICU Medical Inc NDC 00409-7983-02 Lot #85-018-JT, 85-031-JT, 0.9% Sodium Chloride NDC 00409-7984-23 85-016-JT, 85-021-JT, 86-001- Class II ICU Medical Inc Injection NDC 00409-7984-37 JT Exp. 01/20 5% Dextrose Injection NDC 00409-7922-02 Lot #86-033-JT Exp. 08/19 Class II ICU Medical Inc Naloxone Hydrochloride NDC 00409-1782-03 Lot #72680LL, 76510LL RMS Hospira Inc. Injection 0.4mg/ml Lot #0102031800 Gaia Ethnobotanical, Kratom Products No NDC/UPC Provided RMS Batch #031800 LLC

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/ 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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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