According to USFDA, the corporate’s US-based unit is recalling the affected lot attributable 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 said.
Granules initiated the Class II voluntary recall on August 11 this yr.
As per USFDA, a Class II recall is initiated in a state of affairs in which use of, or publicity to, a violative product could trigger short-term or medically reversible adversarial well being penalties or the place the chance of great adversarial well being penalties is distant.
USFDA additional mentioned US-based Jubilant Cadista Pharmaceuticals Inc is recalling 14,544 bottles of Donepezil HCL Tablets, which is used to deal with delicate to reasonable dementia in Alzheimer’s illness.
The firm is recalling the affected lot attributable to it being “subpotent,” it added.
Jubilant Cadista Pharmaceuticals is a fully-owned subsidiary of Cadista Holdings Inc, which is 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 August 20, 2021.
As per USFDA, a Class III recall is initiated in a “state of affairs in which use of, or publicity to, a violative product will not be prone to trigger adversarial well being penalties.”
According to trade estimates, the US generic drug market was estimated to be round USD 115.2 billion in 2019. It is the most important market for pharmaceutical products.