Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has initiated recall of 17 batches of the drug product across different strengths 30 mg, 60 mg and 90 mg Cinacalcet tablets

Earlier in October 2024, Dr.Reddys recalled more than 3Lac bottles of Cinacalcet tablets for the same reason. Accord (Intas) had also recalled more than 25 lots of Cinacalcet tablets due to N-Nitroso-cinacalcet.Cinacalcet tablets are indicated for treating secondary hyperparathyroidism (HPT) and parathyroid carcinoma.

Nitrosamine Impurities in Pharma products are a concern as they are potentially carcinogenic and globally regulatory agencies has set stringent controls over acceptable maximum amount of nitrosamine impurities in drug products

For More on Nitrosamines and NDSRIs

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