# FDA recall D-0631-2020

> **American Health Packaging** · Class II · drug recall initiated 2019-11-01.

## Product

Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio.  (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0631-2020
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-01
- **Report date:** 2020-01-08
- **Termination date:** 2022-08-03

- **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-0631-2020

## Citation

> AI Analytics. FDA recall D-0631-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0631-2020. Source: US FDA. Licensed CC0.

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