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Recall Observatory FDA recall evidence

Drug product

VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251

D-552-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
182 Tablets
Official record key
drug-enforcement:D-552-2014

Official wording

Reason: Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD30180_16, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD60211_8, EXP: 5/21/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD39588_1, EXP: 5/13/2014.

Code information: VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg has the following codes Pedigree: AD30180_19, EXP: 5/9/2014; Pedigree: AD60211_20, EXP: 5/21/2014; Pedigree: AD39588_10, EXP: 5/13/2014.

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