Product: Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: 20191001
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated