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Recall Observatory FDA recall evidence

Drug product

COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065

D-549-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
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

    reason.labeling_packaging · v1.0.0

    mislabeled