Lupin Pharmaceuticals Inc. Recall: Metformin Hydrochloride Extended-release Tablets USP 50
Lupin Pharmaceuticals Inc. Recall: Metformin Hydrochloride Extended-release Tablets USP 50 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Lupin Pharmaceuticals Inc.; Product: Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lup
| Recalling firm | Lupin Pharmaceuticals Inc. |
|---|---|
| Product | Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 |
| Reason for recall | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was distributed throughout the United States. |
| Recall initiated | 20200707 |
| Recall number | D-1382-2020 |
| Category | drug |
| State | MD |
| Country | United States |
$29/mo
Try RecallGuard →