Mumbai: Glenmark Pharmaceuticals, a Mumbai-based drug firm, is recalling 6,528 bottles of a high blood pressure medication in the United States. The recall was triggered by failed dissolution specifications discovered during quality testing.
The product, named Diltiazem Hydrochloride extended-release capsules, was made in India and distributed by Glenmark Pharmaceuticals Inc. located in New Jersey. The recall took place after a dissolution test showed an out-of-specification result.
The US Food and Drug Administration (USFDA) classified the recall as Class II which indicates that using the product might cause temporary or medically reversible health issues, however, the risk of severe consequences is low.
India provides generic medicines around the globe. The nation produces 60,000 different generic brands across 60 therapeutic categories, making up about 20% of the world’s supply. It exports pharmaceuticals to over 200 countries, including the United States, Japan, Australia, and Western Europe.
