Recalls / Class II
Class IID-0519-2024
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 74,440 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-14
- FDA classified
- 2024-05-30
- Posted by FDA
- 2024-06-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0519-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.