Drug recall D-0122-2021
Product
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
Reason for recall
CGMP Deviations
Lots and codes
Lot #s: 7S10115A, Exp. 07/31/2021; 7S10143A, 7S10182B, Exp. 09/30/2021; 7S10255A, 7S10256A, 7S10263A, Exp. 11/30/2021; 7T10028A, 12/31/2021; 7T10040A, Exp. 01/31/2022.
Recall details
- Recalling firm
- Shilpa Medicare Limited, Polepally, Jadcherla, N/A
- Quantity
- 35,931 vials
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 8, 2020
- Terminated
- March 11, 2022
Related products
- Azacitidine – drug information
- NDC 72485-201 Azacitidine · Azacitidine 100 mg/1 · Armas Pharmaceuticals Inc.