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.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0516-2024%22
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