Glenmark Pharma Recalls 15 Lakh Bottles Of ADHD Medication In US: FDA
The recall is due to the 'presence of N-Nitroso Atomoxetine impurity above the FDA-recommended limit'.
Glenmark Pharmaceuticals Ltd. is recalling close to 15 lakh bottles of a generic medication used in the treatment of attention deficit hyperactivity disorder in the US market, according to the Food and Drug Administration.
Glenmark Pharmaceuticals Inc, USA, a subsidiary of the Mumbai-based drugmaker, is recalling around 14.76 lakh bottles of Atomoxetine Capsules in multiple strengths.
The company is recalling the affected lot due to 'CGMP Deviations', the US health regulator said in its latest Enforcement Report.
The recall is due to the "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, the FDA stated.
The company initiated the Class II recall on Jan. 29 this year.
As per the 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.
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.
