Granules India and Jubilant Cadista are recalling different products in the US for different reasons. As per the latest Enforcement Report by the US Food and Drug Administration (FDA), the US-based unit of Granules India is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever.
According to FDA, 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, the report stated.
Granules initiated the Class-II voluntary recall on 11th August this year.
As per FDA, 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.
FDA further said that the US-based Jubilant Cadista Pharmaceuticals 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, which is a part of the Noida-based Jubilant Life Sciences.
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 21st August, 2021.
As per FDA, 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 $115.2 billion in 2019. It is the largest market for pharmaceutical products.