Glenmark Recalls 1.5 Million Bottles of ADHD Drug Atomoxetine in the US Over Impurity Concerns
Glenmark Pharmaceuticals recalls 1.5 million bottles of Atomoxetine ADHD medication in the US due to impurity concerns. Learn about the FDA’s classification, patient impact, and company response.
kowshik Reddy
Glenmark Pharmaceuticals Recalls 1.5 Million Bottles of ADHD Medication in the US Due to Impurity Concerns
Glenmark Pharmaceuticals has recalled approximately 1.5 million bottles of Atomoxetine capsules, a generic medication for Attention Deficit Hyperactivity Disorder (ADHD), from the US market. The move comes following reports of N-Nitroso Atomoxetine impurity levels exceeding those recommended by the USFDA.
Recall Information
- Scope: The recall involves about 1.5 million bottles for different doses of Atomoxetine capsules, from 10 mg to 100 mg
- Reason: N-Nitroso Atomoxetine impurity above the FDA guiding limit was detected.
- Classification: The FDA has classified the recall under Class II. The definition is that use of the violative product may cause temporary or medically reversible adverse health consequences, but the probability of serious consequence is remote.
Company Response
Glenmark Pharmaceuticals accepts there is a problem and is working with the FDA to facilitate the recall. They further emphasize their commitment to upholding high manufacturing standards and are conducting an in-depth investigation to avoid this in the future.
