FDA-Drug2022-08-24Class II
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.
Zydus Pharmaceuticals (USA) Inc
Hazard
Failed Impurities/Degradation Specifications
Sold states
Nationwide.
Affected count
1116 boxes
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1351-2022Don't want to check this manually?
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