Drug product
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
D-0513-2024
Product summary
- Event
- Event 94551
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39,700 vials
- Official record key
drug-enforcement:D-0513-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 23MAY016, Exp. Date 5/8/24; 23JUL016, Exp. Date 7/10/24; 23AUG034, Exp. Date 8/16/24; 23DEC014, Exp. Date 12/10/24
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility