FDA recall D-594-2014

Aidapak Services, LLC · Class II · drug

Product

traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111044101

Reason for recall

Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014.

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-594-2014