Drug product
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
D-0288-2015
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 69688
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,336 bottles
- Official record key
drug-enforcement:D-0288-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Code information: Lot #: 3007330, Exp 11/2014
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification