REGULATORY INTELLIGENCE·Warning Letter
HTO Nevada Inc. dba Kirkman Initiates Nationwide Recall of VASOCAINE Spray Due to Stability Data Deficiencies
HTO Nevada Inc. dba Kirkman has initiated a Class II recall for 27,380 bottles of FIVE-STAR, VASOCAINE Spray (Lidocaine HCl 4%, Racepinephrine HCl 0.01%) across the U.S. The recall, D-0385-2026, stems from stability data failing to support the assigned expiry dates. This event highlights critical supply chain and regulatory risks for procurement and quality assurance teams in the pharmaceutical sector.
90-Day Activity
HTO NevadaFIVE-STARHSN 3004.90
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2026-03-11