New Delhi: 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, the latest Enforcement Report of the US health regulator has said.
Valsartan tablets are used for the treatment of hypertension and heart failure.
The company is recalling 10,577 bottles of Valsartan tablets USP in the strength of 40 mg, 9,552 bottles of the 80 mg tablets, 18,947 bottles of 160 mg tablets and 7,048 bottles of 320 mg tablets, the report added.
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 voluntary, ongoing recall is a class III recall, the report by the United States Food and Drug Administration (USFDA) said.
The product was distributed throughout the United States to wholesalers and retailers, it added.
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.”