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Warning letters, 483s, Recalls, Import Alerts, Audit observations

CDSCO has published list of drugs which were found to be not of standard quality for the month of May 2024, during tests at CDSCO (Central) laboratories and State laboratories of the Drug Control Authority.

The medicines which were found to be not of standard quality included Tablets, Syrups, Injections with active ingredients such as Metoprolol, Bromohexine HCl, Montelukast, Levocetrizine, Diclofenac, Cefuroxime Axetil, Paracetamol, Telmisartan, Amoxycillin, Prednisolone, Dexamethasone, Pantaprazole etc. Most cited quality issues were failure in the test for assay or content and dissolution for tablets. Several injectable products were found to be not of standard quality failing for test of particulate matter. Other quality issues cited include crumbling tablets and labelling issues.

Quality Alert – Central Laboratories

Quality Alert – State Laboratories

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