METFORMIN HYDROCHLORIDE Recall D-0328-2025
Description: Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.
METFORMIN HYDROCHLORIDE Recall D-0328-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0328-2025 |
| Event ID | 96474 |
| Brand | METFORMIN HYDROCHLORIDE |
| Generic Name | METFORMIN HYDROCHLORIDE |
| Manufacturer | METFORMIN HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | METFORMIN HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-520 68462-521 |
| Recall Initiation Date | 20250313 |
| Report Date | 20250416 |
| Classification Date | 20250408 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 786Z46389E |
| Drug Application Number | ANDA212969 |
| Structured Product Labeling (SPL ID) | ef160cca-85e2-440c-997f-0535914b4d3f |
| Structured Product Labeling (SPL Set ID) | 0ef9de1a-b786-4b6c-a250-3f5ac532b16a |
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