REGULATORY INTELLIGENCE·Warning Letter
FDA Mandates Class II Recall for C & A Naturistics' AK Forte Due to Undeclared Diclofenac and Acetaminophen
C & A Naturistics initiated a Class II recall for AK Forte Ortiga y Omega 3 due to undeclared diclofenac and acetaminophen, marketed without FDA approval. This event highlights critical supply chain and regulatory compliance failures. Procurement and regulatory teams must scrutinize suppliers, especially for products lacking proper authorization, to mitigate significant business and patient safety risks.
90-Day Activity
C & A NaturisticsAK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2024-10-30