Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle Supply Disruption — Granules Pharmaceuticals Inc (
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle Supply Disruption — Granules Pharmaceuticals Inc ( is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle; Manufacturer: Granul
| Drug name | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle |
|---|---|
| Manufacturer | Granules Pharmaceuticals Inc |
| Recall/Disruption reason | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-1386-2020 |
| Initiation date | 20200703 |
| Quantity affected | a) 476,073 bottles; b) 2,100 bottles |
| Dosage form | Drugs |
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