Recalls / Class II

Class IID-549-2014

Product

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

Affected lot / code info

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.

Why it was recalled

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

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

341 Capsules

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-549-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.