Sterile ophthalmic solution recalled for subpotent drug strength
Imprimis NJOF is recalling 2,822 bottles of sterile ophthalmic solution because stability testing showed subpotent drug strength below specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported adverse events or injuries. The hazard is reduced therapeutic efficacy rather than direct patient safety risk. This is a quality control and specification compliance issue.
Plain-English summary
Imprimis NJOF, LLC is recalling 2,822 bottles of a combination sterile ophthalmic solution containing tropicamide, proparacaine, phenylephrine, and ketorolac. The recall was initiated because stability testing revealed that the medication is subpotent—that is, the active drug strength falls below the product specifications of 90.0-110.0% of the label claim.
The recalled product is a 5 mL fill in a 15 mL bottle with NDC 71384-733-05. The affected lot is 24OCT041 with expiration date April 26, 2025. The product was distributed in Florida and New York.
If you have received this product, contact your healthcare provider for guidance on whether you should return the medication and seek alternative treatment.
The recalled product
- 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.
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 24OCT041
- Exp 04/26/2025
Distribution
Distributed in 2 states:
- FL
- NY
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