Drug product
PROPAFENONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591058201.
D-966-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-966-2014
Official wording
Reason: Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 00185004109, Pedigree: AD54549_7, EXP: 5/20/2014.
Code information: PROPAFENONE HCL, Tablet, 150 mg has the following codes: Pedigree: AD54549_13, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled