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FDADecember 6, 2021drug

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01

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

05446099301

Recall history

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

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