Drug 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
D-0242-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 69546
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18,493
- Official record key
drug-enforcement:D-0242-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Code information: Lot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Out of specification