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FDAApril 12, 2021drug

Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

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

The hazard

Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

What to do

FDA enforcement status: Terminated

Brands named

edge pharmaedge

UPCs

18029921178

Recall history

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

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Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178 — Recall Details · AllClear