Glenmark recalls 1200 bottles of generic hypertension drug in US over manufacturing issue
New Jersey: Glenmark Pharmaceuticals is recalling 1,200 bottles of a generic drug, used to treat high blood pressure, in the American market due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).
The New Jersey-based arm of the drug firm is recalling 1,200 bottles of Trandolapril and Verapamil Hydrochloride extended-release tablets, as per the latest Enforcement Report of the US health regulator.
The affected lot has been manufactured at the Goa plant of the Mumbai-based drug firm and then supplied to Glenmark Pharmaceuticals Inc, USA, the USFDA said. The firm is recalling the affected bottles due to it being "Subpotent", it noted.
Glenmark Pharmaceuticals Inc initiated the nationwide (US) Class III recall on August 14 this year, it added.
As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences"
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Glenmark Pharmaceuticals Ltd. is an integrated, research‐led, global pharmaceutical company, with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Glenmark’s Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), becoming the second Indian Pharmaceuticals company to achieve this approval.
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