Drug product
NIACIN, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227260.
D-1028-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-1028-2014
Official wording
Reason: Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD54516_1, EXP: 5/20/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W002920, EXP: 6/10/2014.
Code information: NIACIN, Tablet, 500 mg has the following codes: Pedigree: AD52993_10, EXP: 5/20/2014; Pedigree: W002957, EXP: 6/10/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled