Drug product
CYANOCOBALAMIN, Tablet, 100 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536354201.
D-931-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 Tablets
- Official record key
drug-enforcement:D-931-2014
Official wording
Reason: Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 100 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_7, EXP: 5/24/2014.
Code information: CYANOCOBALAMIN, Tablet, 100 mcg has the following codes: Pedigree: AD62840_1, EXP: 5/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled