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
D-829-2013
Product summary
- Event
- Event 65338
- Status
- Terminated
- Classification
- Class II
- Quantity
- A total of 133,968 bottles (units)
- Official record key
drug-enforcement:D-829-2013
Official wording
Reason: Failed Impurity/Degradation Specification; "Related Compound C"
Code information: Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specification