Recalls / Class II
Class IID-0516-2024
Product
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
- Affected lot / code info
- Lot #: 23JUN003, Exp. Date 5/29/2024; 23JUL035, Exp. Date 7/24/2024; 23AUG033, Exp. Date 8/14/2024; 23AUG043, Exp. Date 8/21/2024; 23SEP001, Exp. Date 9/26/2024; 23OCT002, Exp. Date 10/4/2024; 23OCT031, Exp. Date 10/31/2024; 23NOV011, Exp. Date 11/28/2024; 24FEB027, Exp. Date 2/15/2025
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
- 165,920 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-14
- FDA classified
- 2024-05-29
- Posted by FDA
- 2024-06-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0516-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.