Ophthalmic Suspension Recalled for Sterility Concerns

A lack of assurance of sterility has prompted Imprimis NJOF to voluntarily recall 4280 boxes of compounded prednisolone acetate 1%, moxifloxacin 0.5%, and bromfenac 0.075% ophthalmic suspension, according to the June 19, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 5-mL bottles of prednisolone acetate 1%, moxifloxacin 0.5%, and bromfenac 0.075% ophthalmic suspension for topical use, 20 units per box (NDC 71384-310-05), from lot 23NOV018 (Exp. 6/17/24). The product was compounded by Imprimis NJOF, Ledgewood, New Jersey, and was distributed throughout the United States.

Imprimis NJOF initiated the recall on May 14, 2024. On June 7, 2024, the FDA designated the recall Class II. Per the classification, use of the product may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

The prescription suspension consists of a steroid, antibiotic, and nonsteroidal anti-inflammatory drug. Possible indications include postoperative ophthalmic inflammation, postoperative eye pain, and bacterial conjunctivitis, according to the ImprimisRx website.