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Recall Observatory FDA recall evidence

Drug product

HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.

D-959-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
909 Tablets
Official record key
drug-enforcement:D-959-2014

Official wording

Reason: Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN

Code information: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg has the following codes: Pedigree: AD21790_19, EXP: 5/1/2014; Pedigree: AD46265_7, EXP: 5/15/2014; Pedigree: W003679, EXP: 6/25/2014; Pedigree: AD60272_16, EXP: 5/22/2014; Pedigree: AD30140_10, EXP: 5/7/2014; Pedigree: W003000, EXP: 6/11/2014; Pedigree: W003326, EXP: 6/19/2014.

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