D-1351-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 24, 2022
- Initiation Date
- July 15, 2022
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1116 boxes
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide.
Code Information
Lot # B200076; Exp 31 JAN 2024