Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620 Supply Disruption — Teva Pharmaceuticals USA (Mod
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620 Supply Disruption — Teva Pharmaceuticals USA (Mod is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620; Manufacturer: Teva
| Drug name | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 620 |
|---|---|
| Manufacturer | Teva Pharmaceuticals USA |
| 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 | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1331-2020 |
| Initiation date | 20200602 |
| Quantity affected | a) 92,793 bottles and b) 4,824 bottles |
| Dosage form | Drugs |
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