Product: Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20211206
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated