# FDA recall D-1609-2014

> **Apotex Corp.** · Class III · drug recall initiated 2014-04-18.

## Product

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

## Reason for recall

Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1609-2014
- **Recalling firm:** Apotex Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-18
- **Report date:** 2014-10-01
- **Termination date:** 2017-04-07

- **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-1609-2014

## Citation

> AI Analytics. FDA recall D-1609-2014. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1609-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*