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Recall Observatory FDA recall evidence

Drug product

DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884022201

D-587-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Capsules
Official record key
drug-enforcement:D-587-2014

Official wording

Reason: Labeling: Label Mixup; DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD46312_7, EXP: 5/16/2014.

Code information: DOXEPIN HCL, Capsule, 150 mg has the following code Pedigree: AD46312_10, EXP: 5/16/2014.

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