Drug product
COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065
D-549-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 341 Capsules
- Official record key
drug-enforcement:D-549-2014
Official wording
Reason: Labeling: Label Mixup; COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD30180_13, EXP: 5/9/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: AD33897_1, EXP: 5/9/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD37056_1, EXP: 5/10/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 576640
Code information: COENZYME Q-10, Capsule, 100 mg has the following codes Pedigree: AD30180_16, EXP: 5/9/2014; Pedigree: AD32325_4, EXP: 5/9/2014; Pedigree: AD37056_4, EXP: 5/10/2014; Pedigree: AD70655_11, EXP: 5/28/2014; Pedigree: W002711, EXP: 6/6/2014; Pedigree: W003871, EXP: 6/27/2014; Pedigree: W003998, EXP: 7/1/2014; Pedigree: AD68019_4, EXP: 5/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled