Drug product
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
D-0250-2026
Product summary
- Event
- Event 98181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 596 boxes of 11,920 pre-filled syringes
- Official record key
drug-enforcement:D-0250-2026
Official wording
Reason: Presence of particulate matter - Glass like particles.
Code information: Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Distribution pattern: U.S Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter