Recalls / Class III
Class IIID-0243-2015
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
- Affected lot / code info
- Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 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
- 11,062 bottles
- 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-0243-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.