Recalls / Class III
Class IIID-0242-2015
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
- Affected lot / code info
- Lot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, N/A N/A, Canada
Distribution
- Quantity
- 18,493
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-10-16
- FDA classified
- 2014-11-06
- Posted by FDA
- 2014-11-12
- Terminated
- 2016-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0242-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.