Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe,...
FDA Recall #D-0423-2022 — Class II — December 6, 2021
Product Description
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
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
1773 syringes
Distribution
nationwide
Code Information
10-2021-25@5 12/09/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated