REGULATORY INTELLIGENCE·Warning Letter
NCS Healthcare Glycopyrrolate Recall Highlights Critical Impurity Control Failures for Institutional Supply
NCS Healthcare of Kentucky Inc initiated a Class II recall for 6,929 blister cards of Glycopyrrolate Tabs, USP, 1 mg, due to high out-of-specification results for individual unknown impurities. This event, terminated on February 19, 2021, signals critical quality control deficiencies impacting institutional pharmaceutical supply chains. Procurement and regulatory teams must reassess supplier qualification and product quality assurance protocols for similar drug products.
90-Day Activity