Drug recall
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route…
FDA recall event 92848 · Class III · Imprimis NJOF, LLC
Key facts
| Event ID | 92848 |
|---|---|
| Recall numbers | D-1094-2023 |
| Recalling firm | Imprimis NJOF, LLC |
| Product type | Drugs |
| Products | 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. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. |
| Initiation date | Aug 10, 2023 |
| Report date | Aug 30, 2023 |
| Termination date | Jan 22, 2024 |
| City | Ledgewood |
| State | NJ |
| Country | United States |
| FEI number | 3013024146 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: