Nebivolol

Glenmark Pharmaceuticals Inc., USA, has initiated a Class III recall for 672 bottles of Nebivolol Tablets, 20 mg, due to cross-contamination. This event highlights critical manufacturing quality control failures at its Pithampur, India facility, demanding immediate reassessment by procurement and regulatory teams to mitigate supply chain risks and ensure product integrity.

Aurobindo Pharma USA Inc. has initiated a Class II recall of Nebivolol Tablets (2.5 mg) across the USA due to N-Nitroso Nebivolol, a nitrosamine impurity, exceeding acceptable intake limits. This CGMP deviation poses significant regulatory and supply chain risks for procurement and regulatory affairs teams, necessitating immediate assessment of existing stock and sourcing strategies for hypertension treatments.