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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1351-2022 |
| Event ID | 90618 |
| Brand | FULVESTRANT |
| Generic Name | FULVESTRANT |
| Manufacturer | FULVESTRANT |
| Original Package? | 1 |
| Active Substance | FULVESTRANT |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide. |
| Quantity | 1116 boxes |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20220824 |
| Product NDC | 70710-1688 |
| Product NUI | N0000175582 N0000000145 N0000000168 |
| Pharma Class (EPC) | Estrogen Receptor Antagonist [EPC] |
| Recall Initiation Date | 20220715 |
| Report Date | 20220824 |
| Classification Date | 20220817 |
| Address | 73 Route 31 N Pennington, NJ 08534-3601 United States |
| Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 22X328QOC4 |
| Drug Application Number | ANDA215234 |
| 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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