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Recall Observatory FDA recall evidence

Drug product

VITAMIN B COMPLEX, Tablet Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055540

D-561-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
200 Tablets
Official record key
drug-enforcement:D-561-2014

Official wording

Reason: Labeling: Label Mixup; VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003789, EXP: 6/27/2014; prednisoLONE, Tablet, 5 mg, NDC 16477050501, Pedigree: W003627, EXP: 6/25/2014.

Code information: VITAMIN B COMPLEX, Tablet has the following codes Pedigree: W003820, EXP: 6/27/2014; Pedigree: W003628, EXP: 6/25/2014.

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