Major pharmaceutical companies Aurobindo Pharma, Sun Pharma and Jubilant are recalling various products from the US market for various reasons, according to the latest US Food and Drug Administration (USFDA) enforcement report.
While Aurobindo Pharma is recalling cyanocobalamin injection, which is used to treat and prevent vitamin B12 deficiency, Mumbai-based Sun Pharma is recalling a drug used to increase natural tear production in the eyes.
Similarly, Jubilant Cadista recalls a medicine used to treat different inflammatory conditions.
Jubilant Cadista Pharmaceuticals is a wholly owned subsidiary of Cadista Holdings Inc, part of Noida-based Jubilant Life Sciences.
The USFDA said Aurobindo Pharma USA Inc, a unit of the Hyderabad-based pharmaceutical company, is recalling 4,33,809 injection vials of cyanocobalamin for being an “underpotent drug”.
The New Jersey-based company initiated the recall on April 5.
The US health regulator noted that US company Sun Pharmaceutical Industries Inc was recalling 73,030 boxes of Cequa (cyclosporine ophthalmic solution) for being an “under-potency drug”.
Additionally, there were few out-of-specification results obtained for the test and the presence of particulates in the affected lot, the USFDA said as reasons the company initiated 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 Inc is recalling 19,222 bottles of methylprednisolone tablets for being “sub-potent”.
New Jersey-based Macleods Pharma USA Inc is also recalling 4,872 bottles of a drug used to treat or prevent osteoporosis, manufactured in Baddi, Himachal Pradesh, according to US health regulator Macleods Pharma USA Inc. ‘non-conforming content uniformity’.
The USFDA has classified recalls as Class III, which is initiated in a “situation in which use of or exposure to an offending product is not likely to result in adverse health consequences.”
The US generic drug market was estimated at around USD 115.2 billion in 2019. It is the largest pharmaceutical market.
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