Drug recall
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC…
FDA recall event 86530 · Class II · Marksans Pharma Limited
Key facts
| Event ID | 86530 |
|---|---|
| Recall numbers | D-0061-2021, D-0062-2021 |
| Recalling firm | Marksans Pharma Limited |
| Product type | Drugs |
| Products | 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…, Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Initiation date | Oct 2, 2020 |
| Report date | Nov 11, 2020 |
| Termination date | Feb 21, 2024 |
| City | Vasco Da Gama |
| Country | India |
| FEI number | 3006230648 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: