Updated April 14th, 2024 at 10:26 IST

Glenmark Pharmaceuticals recalls blood pressure medication in US market

The affected lot, produced in India, is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for "failed dissolution specifications."

Reported by: Business Desk
Glenmark recalls 6,528 bottles of blood pressure drug in US | Image:Pexels
Advertisement

Glenmark recalls BP medication: 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, according to the US health regulator.

The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, as reported by the US Food and Drug Administration (FDA) in its latest Enforcement Report.

Advertisement

The affected lot, produced in India, is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for "failed dissolution specifications," the USFDA stated. An "Out of Specification (OOS)" was reported in a test of dissolution at the 12-month time point in a long-term stability study.

Glenmark initiated a Class II recall of the drug across the US on March 26 of this year. According to the USFDA, a Class II recall is initiated when the use of a violative product may cause temporary or medically reversible adverse health consequences or when the probability of serious adverse health consequences is remote.

Advertisement

India is the largest supplier of generic medicines, manufacturing 60,000 different generic brands across 60 therapeutic categories. Products manufactured in India are shipped to over 200 countries, with Japan, Australia, West Europe, and the US as the main destinations. India also has the highest number of USFDA-compliant companies with plants outside of the US.

(with PTI inputs

Advertisement

Published April 14th, 2024 at 10:26 IST