FDAHealthFebruary 24, 2025
Imprimis NJOF, LLC — 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, Led
⚠️ 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.
Is this relevant to me?
- Geography
- FL, NY
- Source agency
- FDA
- Category
- Health
- Published
- February 24, 2025
FL and NY
What's affected?
- Product
- 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.
- Brand
- Imprimis NJOF, LLC
- Lot code
- 24OCT041
Additional details
Lot 24OCT041, Exp 04/26/2025
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 2822 bottles.
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