FDAFDA · Food and drugs·Recall number D-0536-2025
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.
Published July 30, 2025 · Recall initiated: July 9, 2025
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sub-Potent Drug: Subpotent assay results during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Imprimis NJOF, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot: 25MAR032, Exp. 07/16/2025.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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