FDA Drug recall D-0516-2024
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 Wes…
- FDA Drug
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 Wes… by Imprimis Njof, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0516-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-14 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Imprimis Njof |
| Distribution | US |
Product
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 23JUN003, Exp. Date 5/29/2024; 23JUL035, Exp. Date 7/24/2024; 23AUG033, Exp. Date 8/14/2024; 23AUG043, Exp. Dat…Lot #: 23JUN003, Exp. Date 5/29/2024; 23JUL035, Exp. Date 7/24/2024; 23AUG033, Exp. Date 8/14/2024; 23AUG043, Exp. Date 8/21/2024; 23SEP001, Exp. Date 9/26/2024; 23OCT002, Exp. Date 10/4/2024; 23OCT031, Exp. Date 10/31/2024; 23NOV011, Exp. Date 11/28/2024; 24FEB027, Exp. Date 2/15/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Imprimis Njof
- Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-51…
FDA Drug · Class II · 2026-01-14 · Imprimis Njof - Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 W…
FDA Drug · Class II · 2026-01-14 · Imprimis Njof - Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West…
FDA Drug · Class II · 2026-01-14 · Imprimis Njof - Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bott…
FDA Drug · Class III · 2025-11-26 · Imprimis Njof - Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Impr…
FDA Drug · Class III · 2025-07-30 · Imprimis Njof
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0516-2024%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.