Imprimis NJOF, LLC 2025-04-09 Health moderate FDA
Health · FDA · Recall #FDA-D-0305-2025
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1%… Recall
Issued April 9, 2025 · Imprimis NJOF, LLC
In April 2025, Imprimis NJOF, LLC recalled the Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1%…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1%… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Imprimis NJOF, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Imprimis NJOF, LLC
- Category
- Health
- Recall date
- April 9, 2025
- Units affected
- Not reported
- Sold at
- FL and NY
- Recall number
- FDA-D-0305-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Imprimis NJOF, LLC has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.