Sun Pharma, Aurobindo recall US market drugs over manufacturing issues

Sun Pharma, Aurobindo recall US market drugs over manufacturing issues

Sun Pharma, Aurobindo recall US market drugs

Leading pharmaceutical companies Sun Pharmaceutical Industries and Aurobindo Pharma have initiated recalls of their products in the United States due to manufacturing issues, as reported by the US Food and Drug Administration (USFDA).

In the most recent Enforcement Report released by the American health regulatory agency, a subsidiary of Mumbai-based Sun Pharma, operating in the United States, is voluntarily recalling 69,707 cartons of Cequa, a cyclosporine ophthalmic solution primarily prescribed for dry eye treatment.

Sun Pharmaceutical Industries Inc., headquartered in New Jersey, is recalling this product due to it being labeled as “Subpotent,” according to the USFDA. The recall, classified as a Class III recall by the USFDA, was initiated on September 7, 2023. It is important to note that Class III recalls are undertaken in situations where the use or exposure to the affected product is not likely to result in adverse health consequences.

Similarly, Aurobindo Pharma, another prominent player in the pharmaceutical industry, is conducting a recall of 9,890 bottles of Rasagiline Tablets, a medication used in the treatment of Parkinson’s disease, in the United States. This recall is being carried out by New Jersey-based Aurobindo Pharma USA Inc., a subsidiary of the Hyderabad-based pharmaceutical giant.

The reason for this recall is stated as “Failed dissolution specifications,” as per the USFDA’s observation. The recall, categorized as a Class II recall, was initiated on August 2, 2023. Class II recalls are put into action when the use or exposure to a defective product may potentially lead to temporary or medically reversible adverse health consequences, with a remote likelihood of causing serious adverse health effects.

It’s noteworthy that the Indian pharmaceutical industry holds the distinction of being the world’s third-largest in terms of volume, boasting a current market size of approximately USD 50 billion. In the fiscal year 2021-22, India’s pharmaceutical exports, including bulk drugs and drug intermediates, amounted to Rs 1,75,040 crore.

About Sun Pharma:

Sun Pharmaceutical Industries Limited, also known as Sun Pharma, is an Indian multinational pharmaceutical corporation with its headquarters situated in Mumbai. The company is engaged in the production and distribution of pharmaceutical formulations and active pharmaceutical ingredients (APIs) worldwide, serving customers in over 100 countries. Sun Pharma holds the distinction of being the largest pharmaceutical company in India and ranks as the fourth-largest specialty generic pharmaceutical company globally.

About Aurobindo:

Aurobindo Pharma Limited stands as an Indian multinational pharmaceutical manufacturing corporation with its headquarters situated in HITEC City, Hyderabad, India. This esteemed company specializes in producing generic pharmaceuticals and active pharmaceutical ingredients.

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