Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Dr...
FDA Recall #D-0400-2022 — Class II — December 6, 2021
Product Description
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
Reason for Recall
Lack of Assurance of Sterility.
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
80 droppers
Distribution
nationwide
Code Information
10-2021-20@1 02/10/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated