Drug product
EXEMESTANE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054008013.
D-793-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-793-2014
Official wording
Reason: Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003473, EXP: 6/20/2014.
Code information: EXEMESTANE, Tablet, 25 mg has the following codes: Pedigree: W003471, EXP: 6/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled