Drug product
VALSARTAN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078042315.
D-819-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-819-2014
Official wording
Reason: Labeling: Label Mixup: VALSARTAN, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD52372_4, EXP: 5/17/2014; ZINC SULFATE, Capsule, 50 mg, NDC 00904533260, Pedigree: AD30994_8, EXP: 5/9/2014.
Code information: VALSARTAN, Tablet, 40 mg has the following codes: Pedigree: AD52372_1, EXP: 5/17/2014; Pedigree: AD32579_1, EXP: 5/9/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled