Recalls / Class III
Class IIID-0536-2025
Product
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
- Affected lot / code info
- Lot: 25MAR032, Exp. 07/16/2025.
Why it was recalled
Sub-Potent Drug: Subpotent assay results during stability testing.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, N/A, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 2,890 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-07-09
- FDA classified
- 2025-07-21
- Posted by FDA
- 2025-07-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0536-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.