FDA Recalls Epinephrine-Lidocaine Intraocular Injections Due to Sterility Concerns

Plain-English summary

Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL preservative-free intraocular injection vials due to lack of sterility assurance. The recall involves 74,440 units distributed nationwide across the United States.

The FDA classified this as a Class II recall. The manufacturer cannot assure that the product meets sterility requirements for injectable medications.

Healthcare facilities and eye care providers who received these vials should stop using them immediately. Affected lot numbers and expiration dates include: 23JUL025 (7/17/2024), 23SEP012 (7/11/2024), 23OCT015 (7/20/2024), 23OCT020 (7/25/2024), 23OCT026 (8/22/2024), 23NOV030 (8/29/2024), 23DEC026 (9/29/2024), 24JAN011 (7/21/2024), 24FEB033 (8/24/2024), and 24JAN050 (8/30/2024).

For questions or to report adverse events, contact Imprimis NJOF, LLC or FDA MedWatch.

The recalled product

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

Manufacturer

Imprimis NJOF, LLC

Category

Drug — Injectable / Intraocular

Hazard

• lack-of-sterility
• infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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