D-1351-2022 Class II Terminated
FDA drug recall D-1351-2022 was initiated by Zydus Pharmaceuticals (USA) Inc on Jul 15, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Jun 18, 2024). Affected quantity: 1116 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 24, 2022
- Initiation Date
- Jul 15, 2022
- Termination Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1351-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026