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.
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