Ophthalmic Solution Recalled Due to Subpotent Ketorolac Levels
MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.
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 illnesses or injuries. The subpotent ketorolac represents a pharmaceutical quality issue rather than an active safety hazard.
Plain-English summary
MYDRIATIC-4 is a sterile ophthalmic solution containing four active ingredients: tropicamide (1%), proparacaine (0.5%), phenylephrine (2.5%), and ketorolac (0.5%), supplied in 5mL bottles by Imprimis NJOF, LLC.
The recall was issued because testing found ketorolac assay levels in affected lots were out of specification, falling below the 90.0-110.0% of label claim range. This means the product does not contain the labeled amount of ketorolac.
Six lots manufactured between December 2022 and May 2024 are affected. These lots were distributed to physician offices nationwide.
Patients who received this product should contact their eye care provider with any questions or concerns about their medication.
The recalled product
- Product
- MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- subpotent
- insufficient-ketorolac
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 (12)
- Lot#s: 22DEC065 (MDU)
- exp: 09/29/2023
- 23JAN024 (MDU)
- exp: 10/13/2023
- 23FEB024 (SDU)
- exp: 11/09/2023
- 23MAR013 (SDU)
- exp: 12/01/2023
- 23MAR033 (SDU)
- exp: 12/16/2023
- 23MAY044 (SDU)
- exp: 03/23/2024
Distribution
Distributed nationwide across the United States.
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