# FDA recall D-0826-2020

> **PD-Rx Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-01-10.

## Product

ranitidine hydrochloride, USP ,150 mg tablets   a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

## Reason for recall

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

## Distribution

AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN

## Key facts

- **Recall number:** D-0826-2020
- **Recalling firm:** PD-Rx Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-10
- **Report date:** 2020-02-12
- **Termination date:** 2021-03-23

- **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-0826-2020

## Citation

> AI Analytics. FDA recall D-0826-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0826-2020. Source: US FDA. Licensed CC0.

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