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

Recall Number: D-0795-2020

Firm: Denton Pharma, Inc.

Classification: Class II

Status: Terminated

Report Date: 20200129

Initiation Date: 20191220

Termination Date: 20231005

CGMP Deviations: Presence of NDMA impurity detected in 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