FDA recall D-620-2014

Aidapak Services, LLC · Class II · drug

Product

tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915

Reason for recall

Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.

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-620-2014