Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0...
FDA Recall #D-0398-2022 — Class II — December 6, 2021
Product Description
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
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
1720 syringes
Distribution
nationwide
Code Information
08-2021-30@1 12/20/2021, 09-2021-21@5 01/03/2022 & 10-2021-18@5 02/07/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated