Glemark Pharma recalls 6,528 bottles of blood pressure medicine in US

15 Apr 2024 , 11:29 AM

Glenmark Pharmaceuticals is recalling 6,528 bottles of a high blood pressure drug from the US market owing to failed disintegration criteria, according to the US health authorities.

The US branch of the Mumbai-based drug company is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, according to the US Food and Drug Administration’s most recent Enforcement Report.

The batch in question, manufactured in India, is being recalled by Glenmark Pharmaceuticals Inc., headquartered in New Jersey, due to “failed dissolution specifications,” as stated by the USFDA.

The USFDA noted that an Out of Specification (OOS) result occurred during a dissolution test conducted at the 12th month time point in a long-term stability study. Consequently, Glenmark Pharmaceuticals initiated a Class II recall of the medication throughout the United States on March 26 of this year.

According to the USFDA, a Class II recall is undertaken when the use or exposure to a violative product may result in transitory or medically recoverable adverse health effects, or when the likelihood of substantial adverse health consequences is low.

India is the world’s largest provider of generic medications, accounting for around 20% of worldwide supply. The country produces 60,000 distinct generic products over 60 therapeutic categories.

The country’s products are sent to over 200 countries worldwide, with the primary destinations being Japan, Australia, West Europe, and the United States. India has the most USFDA-compliant enterprises with factories outside of the US.

At around 11.25 AM, Glenmark Pharma was trading 1.13% lower at ₹1,039.90 per piece, against the previous close of ₹1,051.80 on NSE. The counter touched an intraday high and low of ₹1,060, and ₹1,031 respectively.

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