FDA Drug recall D-0548-2024
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis…
- FDA Drug
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis… by Imprimis Njof, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0548-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-14 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Imprimis Njof |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot: 23NOV018 Exp. 6/17/24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0548-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.