Jubilant Cadista Pharmaceuticals Inc is recalling over 46,000 bottles of Valsartan tablets manufactured by Jubilant Generics Ltd at its Roorkee plant from the American market. Valsartan tablets are used for treatment of hypertension and heart failure.

According to the latest Enforcement Report of the US health regulator, the company is recalling 10,577 bottles of Valsartan tablets USP in the strength of 40 mg, 9,552 bottles of 80 mg tablets, 18,947 bottles of 160 mg tablets and 7,048 bottles of 320 mg tablets.

The tablets are being recalled on account of “Incorrect/undeclared excipient: There is a potential an incorrect grade of excipient was used during manufacturing,” it added.

The USFDA report said that the voluntary, ongoing recall is a class III recall. The product was distributed throughout the United States to wholesalers and retailers. 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’’.

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