Tropicamide - Proparacaine - Phenylephrine - Ketorolac recall: Subpotent
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC…
Why was Tropicamide - Proparacaine - Phenylephrine - Ketorolac recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 24OCT041, Exp 04/26/2025
- 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…
- Recalling firm
- Imprimis NJOF, LLC
- Quantity
- 2822 bottles
- Distribution
- FL and NY
- Recall date
- April 9, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)