Aurobindo Pharma, Sun Pharma recall Rasagiline Tablets, Cequa from US market
The US health regulator stated that Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication indicated for the treatment of Parkinson's disease, from the US.
New Delhi: Leading drug makers Sun Pharmaceutical Industries and Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the US Food & Drug Administration.
As per the latest Enforcement Report issued by the American health regulator, a US-based subsidiary of Mumbai-based Sun Pharma is recalling 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the US market.
The medication is used for the treatment of dry eyes.
New Jersey-based Sun Pharmaceutical Industries Inc is recalling the product for being "Subpotent'', USFDA stated.
The company initiated the nationwide (US) Class III recall on September 7 this year.
As per the 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".
The US health regulator stated that Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication indicated for the treatment of Parkinson's disease, from the US.
New Jersey-based Aurobindo Pharma USA Inc, a unit of the Hyderabad-based drug major, is recalling the affected lot due to "Failed dissolution specifications", the USFDA noted.
Read also: 3 baby formula makers get USFDA warning letter to correct manufacturing process controls
The company initiated the Class II recall in the US on August 2 this year.
As per the 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.
Read also: Popular antacid Digene gel receives warning alert from DCGI, Abbott initiates recall
The Indian pharmaceutical industry is the third largest in the world by volume with a current market size of around USD 50 billion.
India exported pharmaceuticals worth Rs 1,75,040 crore in 2021-22, including bulk drugs/drug intermediates.
Read also: USFDA accepts Sun Pharma NDA for alopecia areata drug Deuruxolitinib
