Drug product
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
D-1570-2014
Product summary
- Firm
- Apotex Corp.
- Event
- Event 69170
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,494 bottles
- Official record key
drug-enforcement:D-1570-2014
Official wording
Reason: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Code information: Lot # KK6086, exp 03/2015, UPC 360505375998.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification