# FDA recall D-1435-2016

> **Apotex Scientific, Inc** · Class III · drug recall initiated 2016-01-26.

## Product

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

## Reason for recall

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

## Distribution

Nationwide, Alaska, Hawaii, and Puerto Rico.

## Key facts

- **Recall number:** D-1435-2016
- **Recalling firm:** Apotex Scientific, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-26
- **Report date:** 2016-07-20
- **Termination date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arlington, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1435-2016

## Citation

> AI Analytics. FDA recall D-1435-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1435-2016. Source: US FDA. Licensed CC0.

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