Dr. Reddy's, Cipla, Aurobindo units recall products in U.S. market
The Hindu
According to the USFDA, Dr. Reddy’s Laboratories is recalling the affected lot of vitamin K deficiency treatment drug due to ‘failed stability specifications’
Leading drug firms Dr. Reddy's Laboratories, Cipla and Aurobindo Pharma are recalling different products in the U.S. market for various issues, according to the U.S. Food and Drug Administration.
As per the enforcement report by the U.S. Food and Drug Administration (USFDA), the U.S.-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".
USFDA further said the US-based arm of domestic drug major Cipla is recalling 9,041 cartons of Arformoterol Tartrate Inhalation Solution, which is used to help control the symptoms of chronic obstructive pulmonary disease (COPD).
The company is recalling the affected lot due to "lack of assurance of sterility: environmental monitoring failure".
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