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Recall Observatory FDA recall evidence

Drug product

LIOTHYRONINE SODIUM, Tablet, 5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001802

D-556-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Tablets
Official record key
drug-enforcement:D-556-2014

Official wording

Reason: Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 16729018201, Pedigree: AD46414_25, EXP: 5/16/2014.

Code information: LIOTHYRONINE SODIUM Tablet, 5 mcg has the following code Pedigree: AD46414_38, 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