Glenmark Pharmaceuticals is recalling near 15 lakh bottles of a generic medication used in the therapy of consideration deficit hyperactivity dysfunction in the U.S. market, in response to the U.S. well being regulator.
Glenmark Pharmaceuticals Inc, USA, a subsidiary of the Mumbai-based drug maker, is recalling round 14.76 lakh bottles of Atomoxetine Capsules in a number of strengths.
The firm is recalling the affected lot resulting from “CGMP Deviations”, the U.S. Food and Drug Administration (USFDA) stated in its newest Enforcement Report.
The recall is because of “presence of N-Nitroso Atomoxetine impurity above the FDA recommended limit,” it added.
New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the made-in-India product in strengths starting from 10 mg to 100 mg, USFDA said.
The firm initiated the Class II recall on January 29 this 12 months.
As per the USFDA, a Class II recall is initiated in a state of affairs in which use of, or publicity to, a violative product could trigger momentary or medically reversible opposed well being penalties or the place the likelihood of critical opposed well being penalties is distant.
ADHD is a neurodevelopmental dysfunction that impacts an individual’s capacity to focus, management impulses, and regulate their exercise ranges.
It is one of the commonest psychological problems affecting youngsters.
Published – March 03, 2025 08:05 am IST
