Drug product
LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591036901.
D-961-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-961-2014
Official wording
Reason: Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD46426_1, EXP: 5/15/2014.
Code information: LOXAPINE, Capsule, 5 mg has the following codes: Pedigree: AD46426_7, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled