# FDA recall D-1661-2012

> **Apotex Corp.** · Class II · drug recall initiated 2007-06-14.

## Product

Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9

## Reason for recall

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1661-2012
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2007-06-14
- **Report date:** 2012-09-05
- **Termination date:** 2012-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1661-2012

## Citation

> AI Analytics. FDA recall D-1661-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1661-2012. Source: US FDA. Licensed CC0.

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