Product: AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for recall: CGMP Deviations: Impurity  N-nitrosodimethylamine (NDMA) found in API
Recall initiated: 20191017
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated