According to the U.S. health agency, Glenmark Pharmaceuticals is recalling over 15 lakh bottles of a generic drug used to treat attention deficit hyperactivity disorder in the U.S. market. Approximately 14.76 lakh bottles of Atomoxetine Capsules in various strengths are being recalled by Glenmark Pharmaceuticals Inc., USA.
Glenmark Pharmaceuticals is a global pharmaceutical company based in India. Founded in 1977, the company has strong presence in dermatology, respiratory, etc and has operations spanning across multiple countries, including the U.S. and Europe.
The U.S. Food and Drug Administration (USFDA) stated in its most recent Enforcement Report that the corporation is recalling the impacted lot because of "CGMP Deviations." The "presence of N-Nitroso Atomoxetine impurity above the FDA recommended limit" is the reason for the recall, it continued.
According to the USFDA, the manufactured-in-India medicine in strengths ranging from 10 mg to 100 mg is being recalled by Glenmark Pharmaceuticals Inc., situated in New Jersey, USA.
According to the USFDA, a Class II recall is started when there is a remote chance of substantial adverse health effects or when using or being exposed to a product that violates the law may result in short-term or medically reversible negative health effects.
The neuro-developmental disease known as ADHD impairs a person's capacity for concentration, impulse control, and activity regulation. ADHD is among the most prevalent mental illnesses that impact kids. In youngsters, attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent mental illnesses. Impulsivity, hyperactivity, and inattention are signs of ADHD.
ADHD is seen as a chronic and incapacitating disorder that affects a person's everyday functioning, interpersonal connections, academic and professional accomplishments, and many other areas of their life. Relationship instability, subpar performance at work or school, low self-esteem, and other issues can result from adult ADHD.
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