Recalls / Class III
Class IIID-0305-2025
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, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
- Affected lot / code info
- Lot 24OCT041, Exp 04/26/2025
Why it was 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.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 2822 bottles
- Distribution pattern
- FL and NY
Timeline
- Recall initiated
- 2025-02-24
- FDA classified
- 2025-03-28
- Posted by FDA
- 2025-04-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0305-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.