Drug product
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
D-0548-2024
Product summary
- Event
- Event 94552
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,280 boxes
- Official record key
drug-enforcement:D-0548-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 23NOV018 Exp. 6/17/24
Distribution pattern: US Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility