Status
Ongoing
Drug Enforcement D-0519-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
June 5, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 74,440 units
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Imprimis NJOF, LLC
- Address
-
1705 Route 46 Ste 6B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0519-2024
- Event ID
- 94553
- Recall initiation date
- May 14, 2024
- Center classification date
- May 30, 2024
- 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
- More code info
- —