New Delhi:
According to the US Food and Drug Administration, leading pharmaceutical companies are calling Dr. Reddy’s Laboratories, Cipla and Aurobindo Pharma returned several products to the US market for various problems.
According to the U.S. Food and Drug Administration (USFDA) enforcement report, the U.S.-based unit of Dr. Reddy’s Laboratories returned 2,838 ampoules of vitamin K deficiency treatment drug Phytonadione Injectable Emulsion.
According to the USFDA, Dr. Reddy’s Laboratories returned the affected batch due to “failed stability specifications”.
“Out-of-spec results have been reported in 12-month aluminum content stability tests,” it said.
dr. Reddy’s started the Class III voluntary recall on September 14 this year.
According to the USFDA, a Class III recall is initiated in a “situation where it is not likely that use of or exposure to a health-infringing product will cause adverse effects.”
USFDA further said that the US-based branch of domestic drug major Cipla is recalling 9,041 boxes of Arformoterol Tartrate Inhalation Solution, which is used to control symptoms of chronic obstructive pulmonary disease (COPD).
The company is recalling the affected party due to “lack of assurance of sterility: failure of environmental monitoring”.
The affected batch was produced by Cipla at its factory in Madhya Pradesh.
Cipla began its Class II recall in the US on September 30, 2022. According to the USFDA, a Class II recall is initiated in a situation where the use of or exposure to an infringing product causes temporary or medically reversible adverse health effects or where the potential for serious adverse health effects is low.
USFDA said that AuroMedics 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 on patients.
The East Windsor-based drug company is recalling the affected party due to the “presence of particulate matter: a piece of metal found in a vial,” according to the USFDA.
AuroMedics began a Class III recall in the US on September 26.
According to industry estimates, the U.S. generic drug market was estimated to be worth about $115.2 billion in 2019. It is the largest market for pharmaceutical products.
(Except for the headline, this story has not been edited by DailyExpertNews staff and has been published from a syndicated feed.)