FDARecalled Oct 25, 2023 · #D-0043-2024
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...
Hazard
Class III — low health risk
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Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. Classification: Class III Distribution: Product was distributed to physician's offices nationwide.
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Imprimis NJOF, LLC
- Model numbers
- —
- UPCs
- —