Glenmark Pharmaceuticals is pulling back 6,528 bottles of medication used for high blood pressure treatment from the American market due to issues with dissolution specifications, PTI reported citing the US Food and Drug Administration (FDA).
The US health regulator in its latest Enforcement Report said that the US branch of the Mumbai-based pharma company is recalling a specific lot of Diltiazem Hydrochloride extended-release capsules.
The affected lot, manufactured in India, is being recalled by Glenmark Pharmaceuticals Inc., based in New Jersey, due to “failed dissolution specifications”, as stated by the US FDA.
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According to the regulator, an “Out of Specification (OOS)” result was noted during a dissolution test conducted at the 12th-month time point in a long-term stability study.
Recall Initiation by Glenmark
Glenmark Pharma in New Jersey has initiated a Class II recall of the medication across the US on March 26, 2024.
In FDA terms, a Class II recall is triggered when the use of or exposure to a problematic product may result in temporary or medically reversible adverse health effects, or when the likelihood of serious adverse health effects is low.
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India holds a significant position in the global pharmaceutical market. It boasts a 20 percent share in global generic medicine supply, manufacturing approximately 60,000 different generic brands across 60 therapeutic categories.
Indian pharmaceutical products are shipped to over 200 countries worldwide, with key destinations including Japan, Australia, Western Europe, and the US. Moreover, India leads in the number of US FDA-compliant companies with manufacturing plants outside the United States.
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(With inputs from PTI)
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Published: 14 Apr 2024, 12:05 PM IST