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Recall Observatory FDA recall evidence

Drug product

LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 00574022001, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574022001.

D-956-2014

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-956-2014

Official wording

Reason: Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as one of the following drugs: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 00574022201, Pedigree: W003152, EXP: 4/30/2014.

Code information: LIOTHYRONINE SODIUM, Tablet, 5 mcg has the following codes: Pedigree: W003153, EXP: 5/31/2014.

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