Drug product
FOSINOPRIL SODIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251102
D-658-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-658-2014
Official wording
Reason: Labeling:Label Mixup; FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: AD65478_1, EXP: 5/29/2014.
Code information: FOSINOPRIL SODIUM, Tablet, 20 mg has the following code Pedigree: AD70690_1, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled