Dr Reddy’s, Cipla & Aurobindo units recall products in US market

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”.

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”. The affected lot has been produced by Cipla at its Madhya Pradesh based plant.

Cipla commenced the Class II recall in the US on September 30, 2022. As per USFDA, 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. USFDA said 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 like dental procedures in patients.

The East Windsor-based drug firm is recalling the affected lot due to the “presence of particulate matter: piece of metal found in a vial”, the USFDA stated.

AuroMedics commenced the Class III recall in the US on September 26. As per industry estimates, the US generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharma products.