Drug product
CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00007337113.
D-777-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 Capsules
- Official record key
drug-enforcement:D-777-2014
Official wording
Reason: Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as the following drug: BUMETANIDE, Tablet, 1 mg, NDC 00093423301, Pedigree: W003224, EXP: 6/17/2014.
Code information: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg has the following codes: Pedigree: W003225, EXP: 6/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled