# FDA recall D-1576-2014

> **Apotex Inc.** · Class II · drug recall initiated 2014-03-24.

## Product

Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

## Reason for recall

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1576-2014
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-24
- **Report date:** 2014-09-10
- **Termination date:** 2014-09-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1576-2014

## Citation

> AI Analytics. FDA recall D-1576-2014. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1576-2014. Source: US FDA. Licensed CC0.

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