Drug product
SIMVASTATIN, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715298.
D-841-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-841-2014
Official wording
Reason: Labeling: Label Mixup: SIMVASTATIN, Tablet, 5 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 13668011390, Pedigree: AD65323_10, EXP: 5/29/2014.
Code information: SIMVASTATIN, Tablet, 5 mg has the following codes: Pedigree: AD65323_13, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled