FDA Recall D-0519-2024

Imprimis NJOF, LLC · Ledgewood, NJ

Class II Ongoing 730 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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

Quantity: 74,440 units

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0519-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Recall initiated: 2024-05-14
Classified by FDA Center: 2024-05-30
FDA published: 2024-06-05
Recalling firm: Imprimis NJOF, LLC
Firm location: Ledgewood, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls