FDA-Drug2025-07-30Class III
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.
Imprimis NJOF, LLC
Hazard
Sub-Potent Drug: Subpotent assay results during stability testing.
Sold states
Nationwide in the USA
Affected count
2,890 vials
Manufactured in
1705 Route 46 Ste 6B, N/A, Ledgewood, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0536-2025Don't want to check this manually?
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