# FDA recall D-0050-2021

> **RemedyRepack Inc.** · Class II · drug recall initiated 2020-10-11.

## Product

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA  NDC 70518-2480-00

## Reason for recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

## Distribution

Product was distributed to one customer in PA.

## Key facts

- **Recall number:** D-0050-2021
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-11
- **Report date:** 2020-11-04
- **Termination date:** 2021-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0050-2021

## Citation

> AI Analytics. FDA recall D-0050-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0050-2021. Source: US FDA. Licensed CC0.

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