Drug 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.
D-1351-2022
Product summary
- Event
- Event 90618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1116 boxes
- Official record key
drug-enforcement:D-1351-2022
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot # B200076; Exp 31 JAN 2024
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications