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FDADecember 6, 2021drug

Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility

What to do

FDA enforcement status: Terminated

Brands named

edge pharmaedge

UPCs

05446101101

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01 — Recall Details · AllClear