FDAFDA · Food and drugs·Recall number D-959-2014
HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
Published January 29, 2014 · Recall initiated: July 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aidapak Services, LLC
- Distributor
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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