Product Safety Recalls

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FULVESTRANT Recall D-1351-2022

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.

FULVESTRANT Recall D-1351-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1351-2022
Event ID90618
Original Package?1
Active SubstanceFULVESTRANT
Quantity1116 boxes
Recall ReasonFailed Impurities/Degradation Specifications
Drug ClassificationClass II
Drug Code Info20220824
Product NDC70710-1688
Product NUIN0000175582 N0000000145 N0000000168
Pharma Class (EPC)Estrogen Receptor Antagonist [EPC]
Recall Initiation Date20220715
Report Date20220824
Classification Date20220817
Address73 Route 31 N
Pennington, NJ 08534-3601
United States
Recalling FirmZydus Pharmaceuticals (USA) Inc
Initial Notification Letter
Unique Ingredient Identifier22X328QOC4
Drug Application NumberANDA215234
Structured Product Labeling (SPL ID)297c22a2-0a7d-4b35-9f11-31a7c75501b8
Structured Product Labeling (SPL Set ID)994edf79-20a5-4e3a-bb35-c4fe3e65acba
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