REGULATORY INTELLIGENCE·Recall
Keystone Industries Initiates Class II Recall for Gelato Benzocaine Gel Due to CGMP Deviations
Keystone Industries has executed a Class II recall (D-0137-2025) for its Gelato Benzocaine 20% Topical Gel Anesthetic. This action stems from critical CGMP deviations where a quality-rejected batch was inadvertently released and shipped. This event underscores significant supply chain risks for distributors and healthcare providers across the USA, Canada, and Latin American markets.
90-Day Activity