Glenmark recalls blood pressure drug over dissolution specifications in US

Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market due to failed dissolution specifications, the US health regulator said.

The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, the US Food and Drug Administration (USDA) said in its latest enforcement report.

The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for 'failed dissolution specifications', the USDA said.

"Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study," it noted.

Glenmark initiated Class Il recall of the drug across the US on March 26.

According to the USFDA, a Class Il recall is initiated in a situation in which the 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.

India is the largest supplier of generic medicines with around 20 percent share in the global supply, with Japan, Australia, West Europe and the US as the main destinations. It manufactures 60,000 different generic brands across 60 therapeutic categories.

India has the highest number of USDA-compliant companies with plants outside of the US.