Drug product
FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115551110.
D-860-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-860-2014
Official wording
Reason: Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the following drug: FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD49448_4, EXP: 5/17/2014.
Code information: FENOFIBRATE, Tablet, 54 mg has the following codes: Pedigree: AD49448_7, EXP: 5/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled