# FDA recall D-0058-2021

> **Direct Rx** · Class II · drug recall initiated 2020-10-12.

## Product

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534  NDC 72189-064-90

## Reason for recall

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

## Distribution

FL

## Key facts

- **Recall number:** D-0058-2021
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-12
- **Report date:** 2020-11-11
- **Termination date:** 2021-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0058-2021

## Citation

> AI Analytics. FDA recall D-0058-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0058-2021. Source: US FDA. Licensed CC0.

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