FDA recall D-0419-2022

Edge Pharma, LLC · Class II · drug

Product

Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01

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-0419-2022