FDA-Drug2022-02-02Class II
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
Edge Pharma, LLC
Hazard
Lack of Assurance of Sterility
Sold states
nationwide
Affected count
163 syringes
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0408-2022Don't want to check this manually?
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