Drug 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.
D-0536-2025
Product summary
- Event
- Event 97183
- Status
- Completed
- Classification
- Class III
- Quantity
- 2,890 vials
- Official record key
drug-enforcement:D-0536-2025
Official wording
Reason: Sub-Potent Drug: Subpotent assay results during stability testing.
Code information: Lot: 25MAR032, Exp. 07/16/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent