Drug product
PHENYTOIN SODIUM ER, Capsule, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071374066.
D-807-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-807-2014
Official wording
Reason: Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003327, EXP: 6/19/2014.
Code information: PHENYTOIN SODIUM ER, Capsule, 30 mg has the following codes: Pedigree: W003331, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled