Drug product
carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832
D-719-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 229 Capsules
- Official record key
drug-enforcement:D-719-2014
Official wording
Reason: Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.
Code information: carBAMazepine ER, Capsule, 200 mg has the following code Pedigree: AD32764_14, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled