Drug product
NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260
D-467-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103 Tablets
- Official record key
drug-enforcement:D-467-2014
Official wording
Reason: Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.
Code information: NIACIN TR, Tablet, 500 mg has the following code Pedigree: W002969, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled