REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: GenoGenix's Thymosin Beta-4 Injection Faces Sterility Assurance Issues, Impacting US Supply Chains
GenoGenix LLC has initiated a Class II voluntary recall for its Thymosin Beta-4 (TB4) for Injection, 15mg, due to a lack of sterility assurance. This US nationwide recall, impacting lot GG060525-001, necessitates immediate action from procurement and regulatory teams to mitigate patient safety risks and supply chain disruptions for this critical injectable peptide.
90-Day Activity
GenoGenix LLCWater For Injection
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2025-10-15 Recall