Sun Pharma recalls 747 bottles of generic diabetes drug in US over cancer-causing impurity
The product has been manufactured at Sun Pharma's Mohali-based manufacturing plant and is being recalled by its US-based subsidiary.;
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New Delhi: Leading drug maker Sun Pharma 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, the US health regulator has said.
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Sun Pharmaceutical Industries is recalling the bottles of RIOMET ER (metformin hydrochloride for extended-release oral suspension) in the American market.
As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP) -- detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
The product has been manufactured at Sun Pharma's Mohali-based manufacturing plant and is being recalled by its US-based subsidiary.
The company initiated the recall on September 23, the USFDA said.
Read also: Sun Pharma to expand specialty business in new geographies including Greater China, Japan
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