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Recall Observatory FDA recall evidence

Drug product

IMIPRAMINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781176401.

D-1002-2014

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-1002-2014

Official wording

Reason: Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110, Pedigree: AD49448_7, EXP: 5/17/2014.

Code information: IMIPRAMINE HCL, Tablet, 25 mg has the following codes: Pedigree: AD49448_10, EXP: 5/17/2014.

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