FDA recall D-959-2014

Aidapak Services, LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-959-2014