FDAHealthJuly 9, 2025
Imprimis NJOF, LLC — 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
⚠️ Sub-Potent Drug: Subpotent assay results during stability testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 9, 2025
Nationwide in the USA
What's affected?
- Product
- 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.
- Brand
- Imprimis NJOF, LLC
- Lot code
- 25MAR032
Additional details
Lot: 25MAR032, Exp. 07/16/2025.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 2,890 vials.
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