Recalls / Class II
Class IID-0250-2026
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.
- Affected lot / code info
- Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Why it was recalled
Presence of particulate matter - Glass like particles.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 596 boxes of 11,920 pre-filled syringes
- Distribution pattern
- U.S Nationwide
Timeline
- Recall initiated
- 2025-12-18
- FDA classified
- 2026-01-02
- Posted by FDA
- 2026-01-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0250-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.