New Delhi: Torrent Pharma is recalling more than 27,000 bottles of its generic drug, used in lowering high blood pressure, in the US market.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), the Ahmedabad-based company is recalling 27,312 bottles of Telmisartan and Hydrochlorothiazide tablets.
The affected lot has been produced in India and later the company has supplied to its US-based subsidiary for distribution in the US, the world’s largest market for generic drugs.
According to the US health regulator, the drugmaker is recalling the affected lot due to it being ”Superpotent; Hydrochlorothiazide.” New Jersey-based Torrent Pharma Inc, a unit of the company, has initiated the Class III nationwide (US) recall of the 40 mg/12.5 mg, 30 count bottles on December 1, this year. Telmisartan Hydrochlorothiazide comprises two medicines, both of which help to control high blood pressure. It is generally used when one medicine alone is not controlling the blood pressure effectively. Lowering blood pressure helps to reduce your risk of having a heart attack or a stroke.
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As per 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.” The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.