FDA DrugsClass II
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Us...
Published: January 14, 2026Recall ID: D-0250-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of particulate matter - Glass like particles.
Product Description & Identification
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Affected Products
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Ledgewood |
| State | NJ |
| Event id | 98181 |
| Address 1 | 1705 Route 46 Ste 6B |
| Code info | Lot: 25APR001A, 25APR001B, Expires: 04/03/2026. |
| Postal code | 07852-9720 |
| Report date | 20260114 |
| Product type | Drugs |
| Product quantity | 596 boxes of 11,920 pre-filled syringes |
| Reason for recall | Presence of particulate matter - Glass like particles. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251218 |
| Initial firm notification | Letter |
| Center classification date | 20260102 |
Overview
- Recalling FirmImprimis NJOF, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S Nationwide