Product: AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
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