Imprimis NJOF, LLC: MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit

Hazard

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Details from the source

Reason for recall: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. Distribution: Product was distributed to physician's offices nationwide. Quantity: 6,228 bags + 15,360 boxes Lot/code info: Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.