REGULATORY INTELLIGENCE·Warning Letter
Aspiro Pharma's Ketorolac Tromethamine Injection Recalled Nationwide by FDA Due to Glass Particulates
Aspiro Pharma Limited has initiated a nationwide Class II recall for multiple lots of Ketorolac Tromethamine Injection, USP, due to glass particulate matter. This action, impacting a critical pain management drug, necessitates immediate supply chain review for procurement directors and regulatory heads. The recall highlights persistent quality control challenges in sterile injectables, demanding enhanced supplier qualification and vigilance for business continuity.
90-Day Activity
Aspiro Pharma LimitedKetorolac Tromethamine
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2025-10-29