Drug product
SIMVASTATIN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715598.
D-842-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-842-2014
Official wording
Reason: Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD21790_67, EXP: 5/1/2014.
Code information: SIMVASTATIN, Tablet, 40 mg has the following codes: Pedigree: AD22845_4, EXP: 5/2/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled