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Recall Observatory FDA recall evidence

Drug product

DOXAZOSIN MESYLATE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00093812001.

D-852-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-852-2014

Official wording

Reason: Labeling: Label Mixup: DOXAZOSIN MESYLATE, Tablet, 1 mg may have potentially been mislabeled as the following drug: PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: W003872, EXP: 6/27/2014.

Code information: DOXAZOSIN MESYLATE, Tablet, 1 mg has the following codes: Pedigree: W003912, EXP: 6/28/2014.

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