Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, Supply Disruption — Marksans Pharma Limited (Mode
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, Supply Disruption — Marksans Pharma Limited (Mode is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg,; Manufacturer: Marks
| Drug name | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, |
|---|---|
| Manufacturer | Marksans Pharma Limited |
| Recall/Disruption reason | CGMP Deviations: detection of 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-0061-2021 |
| Initiation date | 20201002 |
| Quantity affected | a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles |
| Dosage form | Drugs |
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