According to the US Food and Drug Administration, major pharmaceutical companies Dr Reddy’s Laboratories, Cipla and Aurobindo Pharma are recalling various products in the US market for various issues.
According to an enforcement report from the US Food and Drug Administration (USFDA), the US-based unit of Dr Reddy’s Laboratories is recalling 2,838 ampules of phytonadione injectable emulsion, a vitamin K deficiency drug.
According to the USFDA, Dr Reddy’s Laboratories is recalling those affected due to “failed fixture specifications”.
“The results of the specification are reported in a 12-month stability test for aluminum materials,” it said.
Dr Reddy’s started the voluntary recall of Class III on September 14 this year.
According to the USFDA, Class III recalls are initiated “in a situation that is not likely to cause adverse health effects from use of or exposure to the infringing product”.
The USFDA further said that 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 symptoms of chronic obstructive pulmonary disease (COPD).
The company is recalling those affected due to “lack of assurance of sterility: environmental monitoring failure”.
The affected lots are produced by Cipla at its plant in Madhya Pradesh.
Cipla introduced the Class II recall in the US on September 30, 2022. According to the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, the infringing product could result in temporary or medically reversible adverse health consequences or where the potential for serious adverse health consequences is remote. Is.
Auromedix Pharma LLC, a unit of Hyderabad-based Aurobindo Pharma, is recalling 88,080 vials of tranexamic acid injection, which is used to control or prevent excessive or heavy bleeding during various conditions such as dental procedures in patients, the USFDA said. is done.
The USFDA said the East Windsor-based pharmaceutical firm is recalling affected people due to the “presence of particulate matter: a piece of metal found in a vial”.
Auromedics began recalling third grade in the US on September 26.
As per industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)