3 Indian pharma majors recalling products in US
Dr Reddy’s, Cipla, Aurobindo units withdrawing products due to varied reasons including failed stability specifications, lack of assurance of sterility, environmental monitoring failure, presence of particulate matter and piece of metal found in a vial
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New Delhi: Leading drug firms Dr Reddy's Laboratories, Cipla and Aurobindo Pharma are recalling different products in the US market for various issues, according to the US Food and Drug Administration.
As per the enforcement report by the US Food and Drug Administration (USFDA), the US-based unit of Dr Reddy's Laboratories is recalling 2,838 ampules of vitamin K deficiency treatment drug Phytonadione Injectable Emulsion. According to the USFDA, Dr Reddy's Laboratories is recalling the affected lot due to 'failed stability specifications.'
"Out of specification results reported at 12-month stability testing for aluminum content," it stated. Dr Reddy's initiated the Class III voluntary recall on September 14 this year. 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".
