Glenmark Pharma, an India-based drug manufacturer that has been the focal point of a spate of recalls in recent years, has issued another.
This time, the product pull covers about 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine.
Eli Lilly previously sold the branded version of the drug, Strattera, but discontinued all strengths in 2023 after the arrival of generics.
Unlike stimulant-based drugs that make up the bulk of ADHD treatment, including those like Vyvanse and Adderall, atomoxetine is a selective norepinephrine reuptake inhibitor (sNRI).
The recall was triggered by the presence of unacceptable levels of N-nitroso atomoxetine, a possible carcinogen, in multiple Glenmark atomoxetine batches, according to the FDA.
The voluntary pull, which began Jan. 29, covers bottles of the drug in strengths ranging from 10 mg to 100 mg, the FDA said on its Enforcement Report webpage. The ADHD drugs were manufactured in Glenmark’s facility in Goa, India, and were distributed nationwide.
Glenmark has weathered a string of recalls in recent years due to both manufacturing and labelling issues.
In June 2024, the company recalled 114 batches of 750 mg potassium chloride extended-release capsules—or roughly 47 million capsules—over concerns that they failed to dissolve properly.
In December, the company recalled 90,528 bottles of the high blood pressure drug diltiazem hydrochloride in tablet and extended-release forms due to unacceptable levels of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem.
In separate actions in 2023, Glemark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure; 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms; and five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain.
The previous year it recalled 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion that treats skin conditions such as eczema, psoriasis, allergies and rash.
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