FDAFDA · Food and drugs·Recall number D-0305-2025
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.
Published April 9, 2025 · Recall initiated: February 24, 2025
Status when published: Ongoing — 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: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Imprimis NJOF, LLC
- Distributor
- FL and NY
- Lot
- Lot 24OCT041, Exp 04/26/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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