Drug product
FOSINOPRIL SODIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185004109.
D-878-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-878-2014
Official wording
Reason: Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as the following drug: MERCapsuleTOPURINE, Tablet, 50 mg, NDC 00054458111, Pedigree: AD54549_1, EXP: 5/20/2014.
Code information: FOSINOPRIL SODIUM, Tablet, 10 mg has the following codes: Pedigree: AD54549_7, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled