Drug product
NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533
D-500-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 Tablets
- Official record key
drug-enforcement:D-500-2014
Official wording
Reason: Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.
Code information: NIACIN TR, Tablet, 250 mg has the following code Pedigree: W003756, EXP: 5/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled