Mydriatic Solution Recalled

Subpotency concerns have prompted Imprimis NJOF to recall six lots of Mydriatic 4 ophthalmic solution drops. According to the October 25, 2023, US Food and Drug Administration (FDA) Enforcement Report, testing revealed ketorolac assay levels below the 90% to 110% label claim.

The recall affects Mydriatic 4 ophthalmic solution drops (tropicamide 1%, proparacaine 0.5%, phenylephrine 2.5%, and ketorolac 0.5%) in 5-mL bottles (NDC 71384-632-05) from lots 22DEC065 (MDU) (Exp. 9/29/23), 23JAN024 (MDU) (Exp. 10/13/23), 23FEB024 (SDU) (Exp. 11/9/23), 23MAR013 (SDU) (Exp. 12/1/23), 23MAR033 (SDU) (Exp. 12/16/23), and 23MAY044 (SDU) (Exp. 3/23/24). The bottles were distributed to physician offices throughout the US.

Imprimis NJOF voluntarily initiated the recall September 20, 2023. On October 13, 2023, the FDA designated the recall Class III. Under the recall classification, use of the affected product is not likely to cause harm.

Mydriatic 4 is a compounded mydriatic agent.