Glenmark pharmaceuticals are asking back to about 1.5 million bottles of generic drug in the US market. This drug is used in the treatment of concentration and the treatment of hyperactivity disorder (ADHD). According to PTI news, the US health regulator gave this information on Sunday. Glenmark Pharmaceuticals Inc., a Mumbai -based drug manufacturer is asking for about 14.76 lakh bottles of several atomoxetine capsules.
This is why the decision was taken
According to the news, the US Food and Drug Administration (USFDA) said in its latest enforcement report that the company is asking back to the affected consignment due to ‘CGMP deviation’. The decision was taken due to the N-Nitroso Atomoxetine impurities being found more than the USFDA’s fixed limit. The drug regulator stated that Glenmark Pharmaceuticals Ink in New Jersey, USA is asking back to the product made in India with a capacity of 10 mg to 100 mg.
When is recall
The company started Class II recall on 29 January this year. According to the USFDA, Class II recall is initiated in a condition in which the use of violated products or coming into contact with it can lead to temporary or medical adverse health consequences or where severe adverse health results are very low. ADHD is a neurodeaval pantal disorder that affects a person’s ability to focus, control impulses, and regulate their levels of activity. It is one of the most common mental disorders affecting children.
Glenmark will settle the cases
Glenmark Pharmaceuticals recently said that it would pay US $ 7 million to three institutions to settle the cases in the US related to generic drugs. In a regulatory filing, the Mumbai -based drug manufacturer stated that in 2023 it had compromised with three plaintiff groups, called direct buyer plaintiff, retailer plaintiff and final payer plaintiff. It said that four final payments Wadi, Human Inc., Senten, Kaiser Foundation Health Plan, Inc. and United Healthcare Services, Inc. opted to get out of the disposal of 2023.
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