Granules India is recalling over 2.3 crore ranitidine tablets, used to treat ulcers of the stomach and intestines, from the US market. The voluntary ongoing recall is a class II recall. As per the United States Food and Drug Administration (USFDA), a class II recall is initiated in a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The tablets were distributed in Oregon, New York and New Jersey.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
