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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

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

Agency Publication Date: November 6, 2014
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Affected Products

Product: Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3

Lot #: KR3924, KR3926; Exp. 11/15

Lot Numbers:
KR3924
Product: 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

Lot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15

Lot Numbers:
KR3933
KR3935
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

Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15

Product: Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

Lot #: a) KR3955; Exp. 10/15, KV0430, Exp. 11/15 Lot #: b) KT6063; Exp. 10/15

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69546
Status: Resolved
Manufacturer: Apotex Inc.
Manufactured In: Canada
Units Affected: 4 products (13,177 bottles; 18,493; 11,062 bottles; 22,710 bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.