Marksans Pharma Limited Recall: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Relea
Marksans Pharma Limited Recall: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Relea is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Marksans Pharma Limited; Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b
| Recalling firm | Marksans Pharma Limited |
|---|---|
| Product | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50 |
| Reason for recall | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide |
| Recall initiated | 20201002 |
| Recall number | D-0061-2021 |
| Category | drug |
| State | N/A |
| Country | India |
$29/mo
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