Discussion forum for Pharma Quality events, Regulatory Actions

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

Nitrosamine Impurities in Pharmaceutical

Qvents Apps & ToolsNitrosamine and NDSRI Risk Assessment Tools – APIs, Drug Products, Excipients, Water

Qvents
June 28, 2025

NDSRIs: Glenmark Recalls Several Lots of

Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to

Qvents Team
February 6, 2025

Growing Trend of Drug Recalls for NDSRIs

Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the

Qvents Team
December 21, 2024

NDSRI Nitrosocinacalcet: Aurobindo Recal

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has

Qvents Team
December 21, 2024