# FDA recall D-1003-2020

> **American Health Packaging** · Class II · drug recall initiated 2019-11-20.

## Product

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.  NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

## Reason for recall

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1003-2020
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-20
- **Report date:** 2020-03-18
- **Termination date:** 2022-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1003-2020

## Citation

> AI Analytics. FDA recall D-1003-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1003-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*