Imprimis NJOF Initiates Class II Recall of Tri-Moxi+ Intraocular Injection Due to Particulate Matter
Key Takeaways
- Imprimis NJOF, LLC has initiated a voluntary Class II recall of Tri-Moxi+® single-use intraocular injections due to glass-like particulate matter.
- The recall affects specific lots distributed nationwide and remains ongoing.
- Pharmacists should review inventory immediately and follow recall procedures to prevent patient exposure.
Imprimis NJOF, LLC is recalling Tri-Moxi+® (Triamcinolone 9 mg/0.6 mL, Moxifloxacin 0.6 mg/0.6 mL) Single-Use Intraocular Injection, NDC 71384-746-06. The recall encompasses 314 boxes totaling 6280 pre-filled syringes. Affected product includes Lot 25JAN033A and 25JAN033B, with an expiration date of 02/12/2026. The recall is identified as Recall Number D-0251-2026 and is associated with Event ID 98181. Distribution occurred nationwide across the US, and notifications were issued via letter.
The US Food and Drug Administration (FDA) has designated this action as a Class II recall, indicating that exposure to the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious outcomes. The recall was firm-initiated and voluntary, beginning on December 18, 2025, with the FDA center classification dated January 2, 2026. As of this report, the recall status is ongoing, and no press release has been issued.
The recalling firm, Imprimis NJOF, LLC, located at 1705 Route 46 West, Unit 6B, Ledgewood, NJ, initiated the recall after identifying the presence of particulate matter described as glass-like particles in the product. Such particulate contamination in intraocular injections poses a risk of ocular irritation, inflammation, or other complications, prompting the precautionary removal of affected lots from distribution.
Tri-Moxi+® is an intraocular injection combining triamcinolone, a corticosteroid used to reduce inflammation, and moxifloxacin, a fluoroquinolone antibiotic used to prevent or treat bacterial infection. It is commonly used in ophthalmic settings, including postoperative inflammation control and infection prophylaxis following ocular procedures. Pharmacists should ensure affected inventory is quarantined and coordinate returns per firm instructions while advising clinicians of the recall.
Reference
FDA. Enforcement Report. January 14, 2026. Accessed January 15, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
