Denton Pharma, Inc. recalls Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-c
Recalled January 29, 2020 · FDA recall D-0794-2020 · Denton Pharma
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
1,341 bottles
Sold at
Nationwide
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), 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 →