Denton Pharma, Inc. recalls Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only
Recalled January 29, 2020 · FDA recall D-0795-2020 · Denton Pharma
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
467 bottles
Sold at
Nationwide
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
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
Manufacturer(s)
Denton Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →