NEW DELHI, Mar 2: Glenmark Pharmaceuticals is recalling nearly 1.5 million bottles of a generic drug intended for the treatment of attention deficit hyperactivity disorder (ADHD) in the United States, as reported by the US health regulator.
Glenmark Pharmaceuticals Inc., the US branch of the Mumbai-based company, is recalling about 1,476,000 bottles of Atomoxetine Capsules available in various strengths.
The recall is prompted by “CGMP Deviations,” according to the latest Enforcement Report from the US Food and Drug Administration (USFDA).
The issue stems from the presence of N-Nitroso Atomoxetine impurity exceeding the FDA’s recommended limits.
Glenmark Pharmaceuticals Inc., based in New Jersey, is recalling the product manufactured in India, which comes in strengths ranging from 10 mg to 100 mg, as stated by the USFDA.
The Class II recall was initiated on January 29 of this year.
According to the USFDA, a Class II recall is implemented when the use of or exposure to a non-compliant product may lead to temporary or reversible adverse health effects, or when the risk of serious health consequences is minimal.
ADHD is a neurodevelopmental disorder that impairs an individual’s ability to concentrate, manage impulses, and control activity levels.
It is one of the most prevalent mental health disorders among children. (PTI)
