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Recall Observatory FDA recall evidence

Drug product

LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074707090.

D-811-2014

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-811-2014

Official wording

Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014.

Code information: LEVOTHYROXINE SODIUM, Tablet, 175 mcg has the following codes: Pedigree: W003743, EXP: 6/26/2014.

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