Drug product
VALSARTAN, Tablet, 320 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078036034.
D-817-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-817-2014
Official wording
Reason: Labeling: Label Mixup: VALSARTAN, Tablet, 320 mg may have potentially been mislabeled as the following drug: CILOSTAZOL, Tablet, 100 mg, NDC 60505252201, Pedigree: AD65475_4, EXP: 5/28/2014.
Code information: VALSARTAN, Tablet, 320 mg has the following codes: Pedigree: AD65475_7, EXP: 5/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled