Imprimis NJOF, LLC: Drug Recall

Recall #D-0536-2025 · 07/09/2025

Class III: Low Risk

Recall Details

Recall Number
D-0536-2025
Classification
Class III
Product Type
Drug
Recalling Firm
Imprimis NJOF, LLC
Status
Ongoing
Date Initiated
07/09/2025
Location
Ledgewood, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,890 vials

Reason for Recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Product Description

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

Distribution Pattern

Nationwide in the USA

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.