FDA-Drug2020-01-15Class II
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
Natiowide
Affected count
1,309,536 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0642-2020Don't want to check this manually?
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