REGULATORY INTELLIGENCE·Recall
Keystone Industries' Benzocaine Gel Recall: CGMP Violations Impact Global Dental Supply Chains
Keystone Industries initiated a Class II recall (D-0145-2025) for SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL due to critical CGMP deviations. The Quality Unit rejected bulk product from a scratched mixing vessel, yet it was inadvertently released and distributed across the USA, Canada, and Latin America. This event highlights significant supply chain integrity risks for procurement and regulatory teams.
90-Day Activity