# FDA recall D-1333-2020

> **PD-Rx Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-06-05.

## 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); e) 100 tablets (NDC 49483-0623-01)  bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127

## Reason for recall

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

## Distribution

United States.

## Key facts

- **Recall number:** D-1333-2020
- **Recalling firm:** PD-Rx Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-05
- **Report date:** 2020-07-01
- **Termination date:** 2021-11-08

- **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-1333-2020

## Citation

> AI Analytics. FDA recall D-1333-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-1333-2020. Source: US FDA. Licensed CC0.

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