# FDA recall D-0061-2021

> **Marksans Pharma Limited** · Class II · drug recall initiated 2020-10-02.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0061-2021
- **Recalling firm:** Marksans Pharma Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-02
- **Report date:** 2020-11-11
- **Termination date:** 2024-02-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vasco Da Gama, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0061-2021

## Citation

> AI Analytics. FDA recall D-0061-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0061-2021. Source: US FDA. Licensed CC0.

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