Drug 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
D-0519-2024
Product summary
- Event
- Event 94553
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 74,440 units
- Official record key
drug-enforcement:D-0519-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: 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 pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility