Drug recall D-0820-2021
Product
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Reason for recall
Lack of Assurance of Sterility
Lots and codes
Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 30210004 Exp. 01/31/2023; 30210005 Exp. 01/31/2023; 30210006 Exp. 01/31/2023; 30210014 Exp. 02/28/2023; 30210022 Exp. 02/28/2023; 30210028 Exp. 02/28/2023; 30210029 Exp. 02/28/2023; 30210030 Exp. 02/28/2023; 30210031 Exp. 02/28/2023
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 28658 cartons
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 27, 2021
- Terminated
- October 4, 2023
Related products
- Fulvestrant – drug information
- NDC 68462-317 Fulvestrant · Fulvestrant 50 mg/mL · GLENMARK PHARMACEUTICALS INC., USA