Drug product
THIOTHIXENE, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378100101.
D-894-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-894-2014
Official wording
Reason: Labeling: Label Mixup: THIOTHIXENE, Capsule, 1 mg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD46257_1, EXP: 5/15/2014.
Code information: THIOTHIXENE, Capsule, 1 mg has the following codes: Pedigree: AD54549_22, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled