REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Turbare Manufacturing's Avastin Repackaging Fails Sterility Assurance
Turbare Manufacturing initiated a Class II recall for 1,147 syringes of repackaged Avastin 1.25 mg/0.05 mL due to a critical lack of sterility assurance from a quality control process deviation. This event underscores significant supply chain and regulatory risks for procurement and regulatory affairs teams sourcing sterile injectable products, demanding immediate review of supplier qualification protocols.
90-Day Activity