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Recall Observatory FDA recall evidence

Drug product

LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781518392.

D-1009-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
360 Tablets
Official record key
drug-enforcement:D-1009-2014

Official wording

Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD46265_1, EXP: 5/15/2014; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg, NDC 63304029601, Pedigree: AD70629_10, EXP: 5/29/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: W003438, EXP:

Code information: LEVOTHYROXINE SODIUM, Tablet, 88 mcg has the following codes: Pedigree: AD46265_34, EXP: 5/15/2014; Pedigree: AD70629_13, EXP: 5/29/2014; Pedigree: W003439, EXP: 6/20/2014; Pedigree: AD60272_73, 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