# FDA recall D-0243-2015

> **Apotex Inc.** · Class III · drug recall initiated 2014-10-16.

## Product

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0243-2015
- **Recalling firm:** Apotex Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-16
- **Report date:** 2014-11-12
- **Termination date:** 2016-09-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2015

## Citation

> AI Analytics. FDA recall D-0243-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0243-2015. Source: US FDA. Licensed CC0.

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