Sun Pharma recalls Tadalafil tablets in US
Elaborating on the reasons for the Class II recall, the USFDA said: "An incorrect grade of Crospovidone was used to manufacture the product".;
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New Delhi: Drug major Sun Pharmaceutical Industries is recalling over 1.10 lakh bottles of a generic medication used to treat erectile dysfunction in men in the US market due to a manufacturing error.
The US arm of the domestic pharma major is recalling Tadalafil tablets in the American market, according to the latest enforcement report of the US Food and Drug Administration (USFDA).
The Mumbai-based drugmaker is recalling the product in 30-count bottles of 5mg and 20 mg strengths.
The company is recalling 73,957 bottles of 5 mg strength and 36,786 bottles of 20 mg strength, the US health regulator stated.
An affected lot of the medication was manufactured by the drug maker in India and distributed in the US by Princeton, New Jersey-based Sun Pharmaceutical Industries Inc, it said.
Elaborating on the reasons for the Class II recall, the USFDA said: "An incorrect grade of Crospovidone was used to manufacture the product."
Read also: Sun Pharma to launch Molnupiravir under brand name Molxvir in India
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