Glenmark issues a voluntary recall of ulcer drug in US
Glenmark Pharmaceuticals has issued a voluntary recall of some 2,900 bottles of its Ranitidine product from US shelves after a foreign tablet was found in one of the bottles. Ranitidine is used to treat and prevent ulcers in stomach and intestine. Glenmark is a Mumbai based leading company in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity), with seven molecules in various stages of clinical development & pre-clinical development. It operates in around 95 countries around the world. Glenmark’s pharmaceutical products typically specialize in the treatment of Dermatology, Internal Medicine, Pediatrics, Gynecology, ENT and Diabetes.
The US FDA said that the recalled lot was manufactured for Glenmark by Chennai-based contract manufacturer Shasun Pharmaceuticals Ltd. the foreign tablet found in the bottle is identified as Metoprolol tartrate which is used to treat high blood pressure. Company’s spokesperson said that the Corrective actions have been implemented and the recall is limited to only one lot of material. The FDA has classified the recall as Class II, meaning that it is a situation in which “use of or exposure to a violative [sic] product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”