Drug product
NIACIN, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227160.
D-1027-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-1027-2014
Official wording
Reason: Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W002660, EXP: 6/5/2014.
Code information: NIACIN, Tablet, 100 mg has the following codes: Pedigree: W002661, EXP: 6/5/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled