FDA recall D-0412-2022

Edge Pharma, LLC · Class II · drug

Product

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

Distribution

nationwide

Key facts

Status
Terminated
Initiation date
2021-12-06
Report date
2022-02-02
Termination date
2023-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0412-2022