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
Edge Pharma, LLC
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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