FDA recall D-735-2014

Aidapak Services, LLC · Class II · drug

Product

HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910

Reason for recall

Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
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-735-2014