Sun Pharma recalling 747 bottles of generic diabetes drug in US market

12 Oct 2020 Evaluate

Sun Pharmaceutical Industries is recalling 747 bottles of generic diabetes drug in the US due to possibility of the affected lot containing cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit. As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the company is recalling the bottles of RIOMET ER (metformin hydrochloride for extended-release oral suspension) in the American market.

The company initiated the recall on September 23, 2020. The US health regulator has classified it as a Class-II recall, which is initiated in a ‘situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote’.

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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