Product: Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: 20191220
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated