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Recall Observatory FDA recall evidence

Drug product

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

D-0249-2026

December 18, 2025

Class II

Product summary

Firm
Imprimis NJOF, LLC
Event
Event 98181
Status
Ongoing
Classification
Class II
Quantity
778 boxes of 15,540 pre-filled syringes
Official record key
drug-enforcement:D-0249-2026

Official wording

Reason: Presence of particulate matter - Glass like particles.

Code information: Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026

Distribution pattern: U.S Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter