Glenmark Pharmaceuticals: Glenmark recalls 6,528 bottles of blood pressure drug in US

New Delhi: Glenmark Prescription drugs is recalling 6,528 bottles of a medicine used to deal with hypertension within the American market because of failed dissolution specs, the US well being regulator mentioned. The US-based arm of the Mumbai-headquartered drug agency is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, the US Meals and Drug Administration mentioned in its newest Enforcement Report.

The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Prescription drugs Inc for “failed dissolution specs”, the USFDA mentioned.

“Out of Specification (OOS) was reported in a check of dissolution on the twelfth month time level in long-term stability examine,” it famous.

Glenmark initiated Class II recall of the drug throughout the US on March 26 this yr.

As per the USFDA, a Class II recall is initiated in a state of affairs during which the usage of, or publicity to, a violative product could trigger short-term or medically reversible antagonistic well being penalties or the place the likelihood of significant antagonistic well being penalties is distant.

India is the most important provider of generic medicines with round 20 per cent share within the international provide by manufacturing 60,000 completely different generic manufacturers throughout 60 therapeutic classes. The merchandise manufactured within the nation are shipped to over 200 nations across the globe, with Japan, Australia, West Europe and the US as the primary locations.

India has the very best variety of USFDA-compliant corporations with vegetation exterior of the US.