REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Tuscano and Delucia Group's Entropic Labs SARM RAD-140 Marketed Without Approval
Tuscano and Delucia Group (DBA Entropic Labs) initiated a Class II recall for SARM RAD-140 capsules, distributed nationwide. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), containing Selective Androgen Receptor Modulators (SARMs). This highlights critical regulatory compliance failures for procurement and regulatory affairs teams.
90-Day Activity
Tuscano and Delucia GroupEntropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles
PSPriya Subramaniam· Intelligence Analyst2020-01-29