6,528 Bottles of High Blood Pressure Medication Recalled by Glenmark Pharmaceuticals from US Market

Glenmark Pharmaceuticals is in the process of pulling back 6,528 bottles of medication used for high blood pressure treatment from the American market due to issues with dissolution specifications, PTI reported citing the US Food and Drug Administration (FDA).

According to the most recent enforcement report by the US Food and Drug Administration, a specific batch of Diltiazem Hydrochloride Extended Release capsules is being recalled by an American branch based in Mumbai.

The affected lot, manufactured in India, is being recalled by Glenmark Pharmaceuticals Inc., based in New Jersey, due to "failed dissolution specifications", as stated by the US FDA. The regulator states that during the dissolution test, which was performed at a 12th months’ time point in an ongoing long term stability study, "Out of Specification" OOS results were found. On March 26, 2024, Glenmark Pharma of New Jersey started a Class II recall for the product across the United States.

According to the Food and Drug Administration, when temporary or medically reversible adverse reactions may occur while using or in contact with a problematic product which is unlikely to result in serious adverse health consequences, Class II recalls are initiated. India's position on the world pharmaceutical market is strong. It is one of the world's largest suppliers of generic medicines, with a 20 % market share and approximately 60,000 individual generic brands in 60 categories of medicinal products.

India's pharmaceutical products are exported to over 200 countries, with major destinations including Japan, Australia, Western Europe and the United States. In addition, the number of US FDA compliant companies with manufacturing facilities outside the U.S. is significantly higher in India.