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Pharma firms recall products from US amid US FDA verification

Aurobindo Pharma, Sun Pharma and Jubilant are the three companies

Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (US FDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in the eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.

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Jubilant Cadista Pharmaceuticals is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences.
The USFDA stated that Aurobindo Pharma USA Inc, a unit of Hyderabad-based drug major, is recalling 4,33,809 vials of Cyanocobalamin injection for being a “Subpotent Drug”.

The New Jersey-based firm initiated the recall on April 5. The US health regulator noted that US-based Sun Pharmaceutical Industries is recalling 73,030 boxes of Cequa (cyclosporine ophthalmic solution) for being a “Subpotent Drug”.

Besides, there were low out-of-specification results obtained for assay and the presence of particulate matter in the affected lot, USFDA stated as reasons for the company to initiate the recall. The company, a subsidiary of Sun Pharma, initiated the recall on April 1, this year.

The USFDA noted that Salisbury-based Jubilant Cadista Pharmaceuticals is recalling 19,222 bottles of Methylprednisolone tablets for being “Subpotent”. As per the US health regulator, New Jersey-based Macleods Pharma USA Inc is also recalling 4,872 bottles of a drug used to treat or prevent osteoporosis, manufactured at Baddi (Himachal Pradesh) due to “Failed content uniformity specifications.”

The USFDA has classified the recalls as Class III, which 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 generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.

PTI

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