FDAFDA · Food and drugs·Recall number D-1351-2022
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.
Published August 24, 2022 · Recall initiated: July 15, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FULVESTRANT
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide.
- Lot
- Lot # B200076; Exp 31 JAN 2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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