Dr Reddy’s Laboratories, Glenmark Pharma, and Zydus are calling back their products from the US market due to manufacturing issues, the US Food and Drug Administration (USFDA) informed via a report. According to the US health regulator’s latest report, the Princeton-based Dr Reddy’s Laboratories, a part of the Hyderabad-based pharmaceutical company, has issued a recall of 1,656 bottles of Montelukast sodium tablets.
The tablets are meant to prevent wheezing, breathing difficulty, chest tightness, and coughing caused by asthma in adults, reported PTI. According to the USFDA, the firm is calling back the affected products owing to the presence of foreign tablets and capsules. The regulator informed that a foreign tablet was found in a bottle of Montelukast sodium tablets, USP 10mg, known as metoprolol 25 mg. The firm started the Class II voluntary recall on October 13 this year.
The health regulator informed that Glenmark Pharmaceuticals Inc, US, a unit of the Mumbai-based Glenmark Pharma, has issued a recall of 5,856 bottles of Deferasirox tablets for oral suspension. The product is meant to treat hemochromatosis, or iron overload in the blood. The company has recalled the affected product due to failed dissolution specifications, the regulator said. The firm issued the Class II recall on October 20 this year.
Glenmark has also issued a recall of 16,944 bottles of Ranolazine Extended-Release tablets, meant to treat chronic chest pain, in the US due to failed dissolution specifications. The firm began the Class II nationwide recall on October 23, 2023.
The US-based health regulator stated that Zydus Pharmaceuticals Inc, US, has recalled a certain amount of Oxybutynin Chloride extended-release tablets in different doses owing to failed dissolution specifications-out-of-specification test results. The faulted lot was manufactured by Cadila Healthcare Ltd, Baddi, Himachal Pradesh. The company issued a Class II recall on October 19 this year.
According to the USFDA, a Class II recall is started when the use of or exposure to a violative product could cause temporary or medically reversible adverse health consequences or where the chances of serious adverse health consequences is remote.
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