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Recall Observatory FDA recall evidence

Drug product

LEVOTHYROXINE SODIUM, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074706890.

D-810-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
90 Tablets
Official record key
drug-enforcement:D-810-2014

Official wording

Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 125 mcg may have potentially been mislabeled as the following drug: MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD70615_1, EXP: 2/28/2014.

Code information: LEVOTHYROXINE SODIUM, Tablet, 125 mcg has the following codes: Pedigree: AD70633_4, EXP: 5/23/2014.

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