# FDA recall D-1299-2014

> **Apotex Inc.** · Class III · drug recall initiated 2014-03-20.

## Product

Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-1299-2014
- **Recalling firm:** Apotex Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-20
- **Report date:** 2014-05-07
- **Termination date:** 2014-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1299-2014

## Citation

> AI Analytics. FDA recall D-1299-2014. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/D-1299-2014. Source: US FDA. Licensed CC0.

---

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