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Recall Observatory FDA recall evidence

Drug product

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

D-551-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
120 Tablets
Official record key
drug-enforcement:D-551-2014

Official wording

Reason: Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE Tablet may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD73627_23, EXP: 5/30/2014; TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD73686_1, EXP: 5/31/2014.

Code information: VITAMIN B COMPLEX PROLONGED RELEASE Tablet has the following codes Pedigree: AD73627_26, EXP: 5/30/2014; Pedigree: AD76686_1, EXP: 5/31/2014.

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