Drug product
NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074307490.
D-808-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 Tablets
- Official record key
drug-enforcement:D-808-2014
Official wording
Reason: Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC 53191036201, Pedigree: AD60268_4, EXP: 5/22/2014; METAXALONE, Tablet, 800 mg, NDC 64720032110, Pedigree: W003738, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003716, EXP: 6/26/2014; C
Code information: NIACIN ER, Tablet, 500 mg has the following codes: Pedigree: AD60236_4, EXP: 5/22/2014; Pedigree: W003739, EXP: 6/26/2014; Pedigree: W003740, EXP: 6/26/2014; Pedigree: AD73637_1, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled