Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Recall Number: D-0614-2020
Firm: Amneal Pharmaceuticals, Inc.
Classification: Class II
Status: Ongoing
Report Date: 20191218
Initiation Date: 20191122
Termination Date:
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product Description
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.