Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
Reported: November 12, 2014 Initiated: October 16, 2014 #D-0242-2015
Product Description
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 18,493
- Distribution
- Nationwide.
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3. Recalled by Apotex Inc.. Units affected: 18,493.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 12, 2014. Severity: Low. Recall number: D-0242-2015.
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