Drug product
Moxifloxacin 0.8 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 71384-509-08
D-0515-2024
Product summary
- Event
- Event 94551
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,980 vials
- Official record key
drug-enforcement:D-0515-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 23OCT013, Exp. Date 10/10/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility