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

The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular medications  – Alkem’s Taxim-O (Antibiotic Cefixime), Pan D (Pantoprazole + Domperidone for acidity and indigestion), and Sun Pharma’s Rosuvas 10 (Rosuvastatin for lowering cholesterol).

Samples picked up Drug Inspectors in Bihar and Kolkata failed to meet specifications for parameters like identification, assay, and dissolution. The actual manufacturers of these brands have confirmed that the impugned batches were not manufactured by them, and these are spurious drugs.

Spurious or imitation drug products are drug formulations manufactured concealing the true identity of the product and made to resemble other popular brands. Spurious drugs are mostly manufactured by unlicensed anti-social elements. To fight the menace of spurious drugs and poor-quality medicines, drug inspectors from CDSCO and state agencies collect samples from sales and distribution points as part of continuous surveillance, analyses the samples and display the list of spurious drugs on the CDSCO portal.

CDSCO Alert for Spurious Drugs for October 2024

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