FDA-Drug2023-10-25Class III
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Imprimis NJOF, LLC
Hazard
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Sold states
Product was distributed to physician's offices nationwide.
Affected count
6,228 bags + 15,360 boxes
Manufactured in
1705 Route 46 Ste 6B, N/A, Ledgewood, NJ, United States
Products
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0043-2024Don't want to check this manually?
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