FDA-Drug2025-04-09Class III
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.
Imprimis NJOF, LLC
Hazard
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.
Sold states
FL and NY
Affected count
2822 bottles
Manufactured in
1705 Route 46 Ste 6B, Ledgewood, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2025Don't want to check this manually?
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