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.
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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.
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