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Glenmark issues recall of 6,528 bottles of blood pressure medication in the US

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

Glenmark Pharmaceuticals, a Mumbai-based drug firm, is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market. The US Food and Drug Administration reported that the affected lot of Diltiazem Hydrochloride extended-release capsules failed dissolution specifications. The recall was initiated by Glenmark Pharmaceuticals Inc, the US-based arm of the company, due to Out of Specification (OOS) reported in a test of dissolution at the 12th month time point in a long-term stability study.

The affected lot, produced in India, is being recalled across the US. The recall was classified as Class II by the USFDA, indicating that the use of the product may cause temporary or medically reversible adverse health consequences. India is a major supplier of generic medicines globally, manufacturing a wide range of generic brands across various therapeutic categories. The products manufactured in the country are exported to over 200 countries, with the US being one of the main destinations.

With India having the highest number of USFDA-compliant companies with plants outside of the US, this recall raises concerns about quality control and compliance in the pharmaceutical industry. The issue of failed dissolution specifications underscores the importance of rigorous testing and monitoring of medications to ensure their efficacy and safety for patients. Glenmark Pharmaceuticals’ proactive approach in recalling the affected lot demonstrates their commitment to maintaining quality standards in the industry.

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