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Glenmark recalls over 6,500 bottles of blood pressure medication in the US, reports ET HealthWorld

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

Glenmark Pharmaceuticals, based in Mumbai, is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules in the American market due to failed dissolution specifications, as reported by the US Food and Drug Administration. The affected lot, manufactured in India, is being recalled by Glenmark Pharmaceuticals Inc in the US.

The recall was initiated on March 26 this year after an Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in a long-term stability study. This Class II recall was implemented because the use of the violative product may cause temporary or medically reversible adverse health consequences.

India is a major player in the global supply of generic medicines, manufacturing around 60,000 different generic brands across 60 therapeutic categories. The country ships its products to over 200 countries worldwide, with the US being one of the main destinations. India also boasts the highest number of USFDA-compliant companies with manufacturing plants outside of the US.

Overall, this recall by Glenmark Pharmaceuticals sheds light on the importance of stringent quality control measures in the pharmaceutical industry and the need for thorough testing and monitoring of drug products to ensure patient safety and health.

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