# FDA recall D-0366-2022

> **RemedyRepack Inc.** · Class II · drug recall initiated 2021-12-30.

## Product

Metformin 750 mg Extended Release  NDC # 70518-2920-00

## Reason for recall

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

## Distribution

Product was distributed to one direct account in PA.

## Key facts

- **Recall number:** D-0366-2022
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-30
- **Report date:** 2022-01-19
- **Termination date:** 2022-03-28

- **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-0366-2022

## Citation

> AI Analytics. FDA recall D-0366-2022. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0366-2022. Source: US FDA. Licensed CC0.

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