Recalls / Class II
Class IID-1351-2022
Product
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.
- Brand name
- Fulvestrant
- Generic name
- Fulvestrant
- Active ingredient
- Fulvestrant
- Route
- Intramuscular
- NDC
- 70710-1688
- FDA application
- ANDA215234
- Affected lot / code info
- Lot # B200076; Exp 31 JAN 2024
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 1116 boxes
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2022-07-15
- FDA classified
- 2022-08-17
- Posted by FDA
- 2022-08-24
- Terminated
- 2024-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1351-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.