Edge Pharma, LLC recalls Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syring
Recalled February 2, 2022 · FDA recall D-0403-2022 · Edge Pharma
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
627 syringes
Sold at
nationwide
Description
Lack of Assurance of Sterility
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
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →