Drug product
FOSINOPRIL SODIUM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251002
D-657-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-657-2014
Official wording
Reason: Labeling:Label Mixup; FOSINOPRIL SODIUM Tablet, 10 mg may be potentially mislabeled as CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD46414_10, EXP: 5/16/2014.
Code information: FOSINOPRIL SODIUM, Tablet, 10 mg has the following code Pedigree: AD46414_19, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled