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Recall Observatory FDA recall evidence

Drug product

SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001

D-637-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
3,238 Tablets
Official record key
drug-enforcement:D-637-2014

Official wording

Reason: Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014; VALSARTAN, Tablet, 160 mg, NDC 0007803

Code information: SEVELAMER CARBONATE, Tablet, 800 mg has the following codes Pedigree: AD39858_4, EXP: 5/15/2014; Pedigree: AD70629_16, EXP: 5/29/2014; Pedigree: W002778, EXP: 6/6/2014; Pedigree: W002859, EXP: 6/7/2014; Pedigree: W003029, EXP: 6/11/2014; Pedigree: AD56917_4, EXP: 5/21/2014; Pedigree: AD73627_11, EXP: 5/30/2014; Pedigree: W002710, EXP: 6/6/2014; Pedigree: W002623, EXP: 6/4/2014; Pedigree: W003491, EXP: 6/20/2014.

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