Glenmark recalls 15 lakh bottles of ADHD medication in U.S.: USFDA

Glenmark Pharmaceuticals recalls 14.76 lakh bottles of Atomoxetine Capsules in the US due to impurity concerns.

Glenmark Pharmaceuticals is recalling close to 15 lakh bottles of a generic medication used in the treatment of attention deficit hyperactivity disorder in the U.S. market, according to the U.S. health regulator.

Glenmark Pharmaceuticals Inc, USA, a subsidiary of the Mumbai-based drug maker, is recalling around 14.76 lakh bottles of Atomoxetine Capsules in multiple strengths.

The company is recalling the affected lot due to "CGMP Deviations", the U.S. Food and Drug Administration (USFDA) said in its latest Enforcement Report.

The recall is due to "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, USFDA stated.

The company initiated the Class II recall on January 29 this year.

As per the USFDA, 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.