Epinephrine-Lidocaine Intraocular Injection Vials Recalled for Sterility Assurance
Imprimis NJOF, LLC is recalling 14,180 vials of Epinephrine-Lidocaine intraocular injection due to lack of assurance of sterility. These vials were distributed nationwide within the United States.
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 of a pharmaceutical product with sterility assurance defect. No reported illnesses or hospitalizations mentioned in the source text. This meets the criterion for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall of Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for intraocular injection. The product is manufactured by Imprimis NJOF, LLC of Ledgewood, New Jersey.
The recall was initiated due to lack of assurance of sterility. The recall affects two lots: 23APR033 (expiration date May 1, 2024) and 23JUN001 (expiration date June 5, 2024). In total, 14,180 vials were distributed nationwide within the United States.
The recalled product
- Product
- Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials 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 — Intraocular Injection
- Hazard
- Affected units
- 14,180
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 (4)
- Lot #: 23APR033
- Exp. Date 5/1/24
- 23JUN001
- Exp. Date 6/5/24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Imprimis NJOF, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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