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
Reported: November 12, 2014 Initiated: October 16, 2014 #D-0243-2015
Product Description
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.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 11,062 bottles
- Distribution
- Nationwide.
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Inc.. Units affected: 11,062 bottles.
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-0243-2015.
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