D-829-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2013
- Initiation Date
- May 15, 2013
- Termination Date
- May 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A total of 133,968 bottles (units)
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
Reason for Recall
Failed Impurity/Degradation Specification; "Related Compound C"
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.