Drug 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
D-0512-2024
Product summary
- Event
- Event 94551
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,180 vials
- Official record key
drug-enforcement:D-0512-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility