Drug product
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
D-0659-2016
Product summary
- Firm
- Sandoz Inc
- Event
- Event 73035
- Status
- Terminated
- Classification
- Class III
- Quantity
- 277,267 bottles
- Official record key
drug-enforcement:D-0659-2016
Official wording
Reason: Failed Impurities/Degradation Specifications; 9 month stability timepoint
Code information: a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications