Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL)...
FDA Recall #D-0410-2022 — Class II — December 6, 2021
Product Description
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
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
860 syringes
Distribution
nationwide
Code Information
08-2021-26@2 12/09/2021 & 09-2021-23@1 01/05/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated