Drug product
NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
D-1024-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 504 Capsules
- Official record key
drug-enforcement:D-1024-2014
Official wording
Reason: Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD46265_49, EXP: 5/15/2014; MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD60240_14, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002693, EXP: 6/5/2014; GLUCOSAMIN
Code information: NIACIN TR, Capsule, 500 mg has the following codes: Pedigree: AD46257_22, EXP: 5/15/2014; Pedigree: AD60240_17, EXP: 5/22/2014; Pedigree: W002696, EXP: 6/5/2014; Pedigree: AD73521_22, EXP: 5/30/2014; Pedigree: W003318, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled