Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Lot numbers, UPCs & expiration codes
Lot # B200076; Exp 31 JAN 2024
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-1351-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 1116 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-1351-2022, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90618
- Address
- 73 Route 31 N
- Code information
- Lot # B200076; Exp 31 JAN 2024
- Postal code
- 08534-3601
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1351-2022
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 1116 boxes
- Termination date
- Jun 18, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2022