Product: AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated: 20191114
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated