FDA Drug recall D-1094-2023
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood,…
- FDA Drug
- Class III
- terminated
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class III recall of Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood,… by Imprimis Njof, citing subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1094-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-08-10 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Imprimis Njof |
| Distribution | US |
Product
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
Reason
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Identifiers
| code_info | Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1094-2023%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.