Recall
FDAHealthDecember 18, 2025

Imprimis NJOF, LLC — 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

⚠️ Presence of particulate matter - Glass like particles.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 18, 2025

U.S Nationwide

What's affected?

Product
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.
Lot code
25APR001A

Additional details

Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 596 boxes of 11,920 pre-filled syringes.

View original FDA notice →

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