# FDA recall D-1356-2020

> **Marksans Pharma Limited** · Class II · drug recall initiated 2020-06-05.

## Product

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, 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 Intl. Estate, Verna, Goa-403 722, India   NDC 49483-623-01

## Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1356-2020
- **Recalling firm:** Marksans Pharma Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-05
- **Report date:** 2020-07-01
- **Termination date:** 2023-09-07

- **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-1356-2020

## Citation

> AI Analytics. FDA recall D-1356-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1356-2020. Source: US FDA. Licensed CC0.

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