FDA Drugs recall ·
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic… recall
- Recall number
- D-0305-2025
- Date
- (initiated February 24, 2025)
- Company / brand
- Imprimis NJOF, LLC
1705 Route 46 Ste 6B, Ledgewood, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 2822 bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 24OCT041, Exp 04/26/2025
Distribution
FL and NY
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0305-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.