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Recall Observatory FDA recall evidence

Drug product

TERAZOSIN HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781205301.

D-1004-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
100 Capsules
Official record key
drug-enforcement:D-1004-2014

Official wording

Reason: Labeling: Label Mixup: TERAZOSIN HCL, Capsule, 5 mg may have potentially been mislabeled as the following drug: DOXAZOSIN MESYLATE, Tablet, 1 mg, NDC 00093812001, Pedigree: W003912, EXP: 6/28/2014.

Code information: TERAZOSIN HCL, Capsule, 5 mg has the following codes: Pedigree: W003913, 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