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Recall Observatory FDA recall evidence

Drug product

LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901

D-555-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
102 Tablets
Official record key
drug-enforcement:D-555-2014

Official wording

Reason: Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.

Code information: LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg has the following code Pedigree: AD30197_19, EXP: 3/31/2014.

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