New Delhi : 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, Batch # 19224744 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.
Subpotent means ‘Out of Specification for Assay Test at the 3-month time point.’
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”.