Drug 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
D-0243-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 69546
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,062 bottles
- Official record key
drug-enforcement:D-0243-2015
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 #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Out of specification