MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0....
FDA Recall #D-0412-2022 — Class II — December 6, 2021
Product Description
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
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
199 syringes
Distribution
nationwide
Code Information
11-2021-01@2 12/15/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated