FDA recall D-829-2013

Actavis South Atlantic LLC · Class II · drug

Product

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA

Reason for recall

Failed Impurity/Degradation Specification; "Related Compound C"

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-15
Report date: 2013-08-07
Termination date: 2014-05-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sunrise, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-829-2013