Imprimis NJOF Voluntarily Recalls Ophthalmic Solution Due to Subpotency

Imprimis NJOF, LLC has issued a voluntary recall of its Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution (1% / 0.5% / 2.5% / 0.5%) after stability testing revealed subpotent results. The affected product, packaged as a 5 mL fill in a 15 mL bottle (NDC: 71384-733-05), failed to meet the labeled specification range of 90.0%-110.0% of active ingredient content. The impacted batch is Lot#24OCT041, with an expiration date of April 26, 2025, and includes 2822 bottles distributed in Florida and New York.

The US Food and Drug Administration (FDA) classified this recall as a Class III event (Recall Number D-0305-2025), indicating that use of the product is not likely to cause adverse health consequences. Despite the lower-than-labeled potency, the voluntary recall was initiated by the firm as a precautionary measure to ensure product quality and compliance with safety standards. The recall remains ongoing, and no public press release has been issued at this time.

This sterile ophthalmic solution is commonly used to dilate pupils, anesthetize the eye, reduce inflammation, and control pain during ophthalmic procedures or examinations. Pharmacists are encouraged to check inventory for the affected lot and consult with prescribing physicians regarding potential product replacement.