FDA recall D-0519-2024

Product

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-05-14

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2024