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

Recall Number: D-829-2013

Firm: Actavis South Atlantic LLC

Classification: Class II

Status: Terminated

Report Date: 20130807

Initiation Date: 20130515

Termination Date: 20140515

Reason for Recall

Failed Impurity/Degradation Specification; "Related Compound C"

Product Description

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