Drug product
FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378802077.
D-910-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Capsules
- Official record key
drug-enforcement:D-910-2014
Official wording
Reason: Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, NDC 00603254421, Pedigree: W002654, EXP: 6/4/2014.
Code information: FLUVASTATIN, Capsule, 20 mg has the following codes: Pedigree: 00378802077, EXP: W002655.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled