Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0....
FDA Recall #D-0402-2022 — Class II — December 6, 2021
Product Description
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
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
2568 syringes
Distribution
nationwide
Code Information
10-2021-18@4 12/08/2021& 11-2021-01@3 12/22/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated