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.
Reported: August 24, 2022 Initiated: July 15, 2022 #D-1351-2022
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
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 1116 boxes
- Distribution
- Nationwide.
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 1116 boxes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1351-2022.
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