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Recall Observatory FDA recall evidence

Drug product

NEFAZODONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093711306.

D-840-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
60 Tablets
Official record key
drug-enforcement:D-840-2014

Official wording

Reason: Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD46414_35, EXP: 5/16/2014.

Code information: NEFAZODONE HCL, Tablet, 150 mg has the following codes: Pedigree: AD46414_41, 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