# FDA recall D-0318-2020

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

## Product

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716

## Reason for recall

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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0318-2020
- **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-0318-2020

## Citation

> AI Analytics. FDA recall D-0318-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0318-2020. Source: US FDA. Licensed CC0.

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