Product: Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
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