New Delhi, March 2, 2025 – Glenmark Pharmaceuticals, through its US-based subsidiary, Glenmark Pharmaceuticals Inc, has issued a recall of approximately 1.48 million bottles of Atomoxetine Capsules from the US market. Atomoxetine is a generic medication widely prescribed for Attention Deficit Hyperactivity Disorder (ADHD).
Reason Behind Glenmark Pharmaceuticals' Recall
The recall was announced due to violations of Current Good Manufacturing Practice (CGMP) regulations, specifically involving the detection of N-Nitroso Atomoxetine impurity above the acceptable limits set by the US Food and Drug Administration (USFDA). This impurity prompted the company to proactively initiate a Class II recall.Understanding the USFDA Class II Recall
The recall, categorized as Class II by the USFDA, indicates that using or being exposed to the affected product may lead to temporary or medically reversible adverse health consequences. However, the likelihood of serious health issues arising from this impurity remains low.The recall officially commenced on January 29, 2025, according to the latest USFDA Enforcement Report.
Details of the Recalled Atomoxetine Capsules
The affected Atomoxetine Capsules are manufactured in India and distributed in the US market through New Jersey-based Glenmark Pharmaceuticals Inc. The recall covers capsules available in multiple strengths, ranging from 10 mg to 100 mg.ADHD and Its Prevalence
ADHD, a neurodevelopmental disorder, primarily impacts the individual's ability to maintain attention, manage impulses, and regulate activity levels. It remains one of the most frequently diagnosed mental health disorders in children globally.Glenmark Pharmaceuticals is headquartered in Mumbai and maintains a significant presence in the US market through its subsidiary.
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