Product: Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20211206
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated