FINASTERIDE Recall D-0391-2023
Description: Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2
FINASTERIDE Recall D-0391-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0391-2023 |
| Event ID | 91657 |
| Brand | FINASTERIDE |
| Generic Name | FINASTERIDE |
| Manufacturer | FINASTERIDE |
| Original Package? | 1 |
| Active Substance | FINASTERIDE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 1,440,652 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 71713-096 |
| Product NUI | N0000175836 N0000000126 |
| Drug UPC | 0371713096902 371713096902 |
| Pharma Class (EPC) | 5-alpha Reductase Inhibitor [EPC] |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 57GNO57U7G |
| Drug Application Number | ANDA091643 |
| Structured Product Labeling (SPL ID) | ecdd4925-db44-f8de-e053-2995a90a83ed |
| Structured Product Labeling (SPL Set ID) | df82de18-6113-4644-a54d-b57b646956c6 |
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