Imprimis NJOF, LLC: Drug Recall

Recall #D-0305-2025 · 02/24/2025

Class III: Low Risk

Recall Details

Recall Number
D-0305-2025
Classification
Class III
Product Type
Drug
Recalling Firm
Imprimis NJOF, LLC
Status
Ongoing
Date Initiated
02/24/2025
Location
Ledgewood, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2822 bottles

Reason for Recall

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Product Description

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

Distribution Pattern

FL and NY

Other Recalls by Imprimis NJOF, LLC

View all recalls by Imprimis NJOF, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.