# FDA recall D-0319-2020

> **Apotex Inc.** · Class II · drug recall initiated 2019-09-24.

## Product

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

## Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0319-2020
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2019-09-24
- **Report date:** 2019-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North York, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0319-2020

## Citation

> AI Analytics. FDA recall D-0319-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/D-0319-2020. Source: US FDA. Licensed CC0.

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