Product: Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: 20191202
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated