Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Recalled January 15, 2020 · FDA recall D-0644-2020 · Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
1,712,632 bottles
Sold at
Natiowide
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →