Fagron Compounding Services recalls Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottl
Recalled December 6, 2023 · FDA recall D-0125-2024 · Fagron Compounding Services
Hazard
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper · FDA Class III
Units
756 bottles
Sold at
Nationwide in the USA
Description
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Product
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01
Manufacturer(s)
Fagron Compounding Services
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →