Glenmark Pharma recalls 6528 bottles of BP drug in US

Published On 2024-04-15 08:06 GMT | Update On 2024-04-15 08:06 GMT

New Delhi: Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication prescribed for the treatment of high blood pressure in the American market. The decision comes in response to failed dissolution specifications, as stated by the US health regulator.The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release...

New Delhi: Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication prescribed for the treatment of high blood pressure in the American market. The decision comes in response to failed dissolution specifications, as stated by 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, the US Food and Drug Administration 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 USFDA 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 II recall of the drug across the US on March 26 this year, as per PTI reported.

Read also: Sun Pharma recalls 55000 bottles of generic drug to treat gout from American market

As per the USFDA, a Class II 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 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

Read also: Kenya drug regulator recalls a batch of JnJ children cough syrup

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the US as the main destinations.

India has the highest number of USFDA-compliant companies with plants outside of the US. As per the fiscal year, 2022 report on State of Pharmaceutical Quality published by USFDA, India boasts of more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the US.

Read also: Glenmark, Lupin and 1 other recall products in US over manufacturing issues

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Glenmark Pharma recalls 6528 bottles of BP drug in US

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