Product: Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated: 20191122
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated