Glenmark Pharmaceuticals’ US-based unit has announced the recall of 6,528 bottles of Diltiazem Hydrochloride extended-release capsules for treating high blood pressure.
As per the US Food and Drug Administration’s (FDA) latest Enforcement Report, the recall has been classified as Class II.
As the medication did not meet the dissolution specifications, it prompted the recall in the US market.
The recall initiated by Glenmark on 26 March is intended for the affected lot produced in India.
According to the US FDA, the issue was identified as “Out of Specification (OOS) results in a dissolution test at the 12-month time point during a long-term stability study.”
A Class II recall is defined by the FDA as a case where the usage or exposure to a violative product could lead to temporary or medically reversible adverse health consequences, or where the possibility of serious adverse health outcomes is remote, news agency PTI noted.
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By GlobalData
India holds a significant position in the global pharmaceutical market, being the largest supplier of generic medicines. The country contributes approximately 20% to the global supply, manufacturing 60,000 different generic brands across 60 therapeutic categories.
The pharmaceutical products manufactured in India are exported to more than 200 countries, with key destinations including Australia, Japan, western Europe and the US.
Notably, India is home to the highest number of US FDA-compliant pharma companies with plants outside the US.
In September last year, Glenmark Pharmaceuticals signed a definitive agreement to divest a 75% stake in its Glenmark Life Sciences division (GLS) to Indian company Nirma for Rs56.51bn ($679.85m).
GLS focuses on manufacturing active pharmaceutical ingredients.
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