Subpotent Ophthalmic Solution Recalled

Imprimis NJOF is recalling 3320 bottles of compounded prednisolone sodium phosphate 1%, moxifloxacin 0.5%, and bromfenac 0.075% ophthalmic solution. According to the May 8, 2024, US Food and Drug Administration (FDA) Enforcement Report, the solution is subpotent.

The recall affects 8-mL bottles of prednisolone sodium phosphate 1%, moxifloxacin 0.5%, and bromfenac 0.075% ophthalmic solution (NDC 71384-340-08) from lot 23JUN031 (Exp. 7/3/24). The solution was compounded by Imprimis NJOF, Ledgewood, New Jersey, and was distributed throughout the United States.

Imprimis NJOF voluntarily initiated the recall April 10, 2024. On April 29, 2024, the FDA designated it Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

The solution 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.