FDA-Drug2022-02-02Class II
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
Hazard
Lack of Assurance of Sterility
Sold states
nationwide
Affected count
627 syringes
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0403-2022Don't want to check this manually?
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