FDA Recalls Epinephrine-Lidocaine Intraocular Injections Due to Sterility Concerns
Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard (lack of sterility assurance) is theoretical, placing the score at 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
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
- Affected units
- 74,440
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 23JUL025
- Exp. Date 7/17/2024
- 23SEP012
- Exp. Date 7/11/2024
- 23OCT015
- Exp. Date 7/20/2024
- 23OCT020
- Exp. Date 7/25/2024
- 23OCT026
- Exp. Date 8/22/2024
- 23NOV030
- Exp. Date 8/29/2024
- 23DEC026
- Exp. Date 9/29/2024
- 24JAN011
- Exp. Date 7/21/2024
- 24FEB033
- Exp. Date 8/24/2024
- 24JAN050
- Exp. Date 8/30/2024
Distribution
Distributed nationwide across the United States.
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