D-0820-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- August 27, 2021
- Termination Date
- October 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28658 cartons
Product Description
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
Distribution Pattern
Nationwide.
Code Information
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