Why it was recalled
Lack of Assurance of Sterility
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
Lot numbers, UPCs & expiration 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
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0820-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 27, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 28658 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0820-2021, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88591
- Address
- 750 Corporate Dr
- 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
- Postal code
- 07430-2009
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0820-2021
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 28658 cartons
- Termination date
- Oct 4, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2021