# FDA recall D-0059-2021

> **PD-Rx Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-10-06.

## Product

metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

## Reason for recall

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

## Distribution

AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI

## Key facts

- **Recall number:** D-0059-2021
- **Recalling firm:** PD-Rx Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-06
- **Report date:** 2020-11-11
- **Termination date:** 2021-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oklahoma City, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0059-2021

## Citation

> AI Analytics. FDA recall D-0059-2021. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-0059-2021. Source: US FDA. Licensed CC0.

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