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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during Aug 2024. Fortyeight incidents of Not of Standard Quality drugs are reported by the Central Laboratories (Chandigarh, Kolkata and Guwahati) in August 2024. The list includes key and popular medicines including Amoxicillin, Metformin, Paracetamol, Pantoprazole, Ciprofloxacin, Telmisartan, Alprazolam. Around 16 cases reported issue with assay and eleven cases with dissolution. Other quality issues observed include particulate matter in injections, failure for microbiology parameters like sterility, endotoxins. Two cases of spurious drug issues are also observed involving Amoxicillin And Potassium Clavulanate Tablets and Pantoprazole capsules of Alkem Healthscience.
Eleven incidents were also reported by state laboratories (Thiruvanthapuram, Kerala). The list of Not of Standard Quality (NSQ) drugs published by state laboratories include Ayurvedic preparations like Haridrakhandam, Yogaraja Guggulu, Kudajarishtam
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