The company is recalling the affected lot due to “CGMP Deviations”, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The recall is due to “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 ranging from 10 mg to 100 mg, USFDA stated.
The company initiated the Class II recall on January 29 this year.
As per the 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. ADHD is a neurodevelopmental disorder that affects a person’s ability to focus, control impulses, and regulate their activity levels.
It is one of the most common mental disorders affecting children.
