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Recall Observatory FDA recall evidence

Drug product

LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.

D-922-2014

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-922-2014

Official wording

Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD60272_19, EXP: 5/22/2014.

Code information: LEVOTHYROXINE SODIUM, Tablet, 112 mcg has the following codes: Pedigree: AD60272_22, EXP: 5/22/2014.

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