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Granules India and Jubilant Cadista, two generic drug manufacturers, are recalling several goods in the United States, the world’s largest market for medicines, for various reasons. According to the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), Granules India’s US-based unit is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, and inflammatory diseases such as rheumatoid arthritis, gout and fever.
According to USFDA, the company’s US-based unit is recalling the affected lot due to ‘Current Good Manufacturing Practice (CGMP) deviations’.
The affected lot has been manufactured at Granules India’s Telangana-based plant. The lot has been distributed in the US by New Jersey-based Granules USA, Inc, the report stated.
Granules initiated the Class II voluntary recall on 11th August this year.
As per 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.
USFDA further said US-based Jubilant Cadista Pharmaceuticals Inc is recalling 14,544 bottles of Donepezil HCL Tablets, which is used to treat mild to moderate dementia in Alzheimer’s disease.
The company is recalling the affected lot due to it being ‘subpotent,’ it added.
Jubilant Cadista Pharmaceuticals is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.
The affected lot has been produced by Jubilant Generics in India and marketed in the US by Salisbury-based Jubilant Cadista Pharmaceuticals, Inc.
Jubilant commenced the Class III recall in the US on 20th August 2021.
As per 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.’
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.