Drug product
SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904316260.
D-1029-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-1029-2014
Official wording
Reason: Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP: 5/21/2014.
Code information: SELENIUM, Tablet, 50 mcg has the following codes: Pedigree: AD56939_1, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled