# FDA recall D-0153-2020

> **Apotex Inc.** · Class III · drug recall initiated 2019-10-22.

## Product

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326  NDC 60505-2580-8

## Reason for recall

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

## Distribution

IL, MS, NJ, OH, TX

## Key facts

- **Recall number:** D-0153-2020
- **Recalling firm:** Apotex Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-22
- **Report date:** 2019-11-06
- **Termination date:** 2026-02-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2020

## Citation

> AI Analytics. FDA recall D-0153-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0153-2020. Source: US FDA. Licensed CC0.

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