Dr Reddy's, Glenmark, and Zydus Recall Products in the US Over Manufacturing Issues

22 Nov 2023 , 03:44 PM

Dr Reddy’s Laboratories, Glenmark Pharma, and Zydus are recalling products in the US market due to manufacturing issues, as per the US Food and Drug Administration (USFDA). 

• Dr Reddy’s Laboratories, Inc., a unit of the Hyderabad-based firm, is recalling 1,656 bottles of Montelukast sodium tablets used to prevent asthma symptoms. The recall is attributed to the ‘presence of foreign tablets and capsules,’ with a foreign tablet identified as metoprolol 25 mg found in a bottle of Montelukast sodium tablets, USP 10mg.
• Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharma, is recalling 5,856 bottles of Deferasirox tablets for oral suspension, used to treat iron overload. The recall is due to ‘failed dissolution specifications.’ Glenmark Pharmaceuticals Inc is also recalling 16,944 bottles of Ranolazine Extended-Release tablets, used for chronic chest pain, in the US due to ‘failed dissolution specifications.’
• Zydus Pharmaceuticals (USA) Inc is recalling Oxybutynin Chloride extended-release tablets in different strengths due to ‘failed dissolution specifications-out-of-specification test results.’ The affected lot was manufactured by Cadila Healthcare Ltd, Baddi, Himachal Pradesh.

The recalls are classified as Class II, where the use or exposure to the violative product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health consequences, according to the USFDA.

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