Edetate Disodium recalled over sterility concerns

Recall date

December 6, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Edge Pharma, LLC recalls Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical O…

Recall number

D-0400-2022

FDA classification

Class II

Brand / firm

Edge Pharma, LLC

Sold / distributed

nationwide

Why it was recalled

Lack of Assurance of Sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10