Three pharma companies recall products in US
The three pharma companies -- Dr Reddy's Laboratories, Cipla and Aurobindo Pharma -- are recalling different products in the US market for various issues
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 (FDA).
As per the enforcement report by FDA, 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 FDA, 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 14th September this year.
As per the FDA, 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.”
The FDA further said the US-based arm of 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.”
The affected lot has been produced by Cipla at its Madhya Pradesh-based plant.
It commenced the class-II recall in the US on 30th September, 2022. As per FDA, a class-II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The FDA said AuroMedics Pharma, a unit of 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 like dental procedures in patients.
The drug firm is recalling the affected lot due to the “presence of particulate matter: piece of metal found in a vial,” the FDA stated.
AuroMedics commenced the class-III recall in the US on 26th September, 2022.