FDA recall D-0424-2022

Product

Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01

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-0424-2022