NEW DELHI, Oct 8: 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.
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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.
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.
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. (PTI)
