FDARecalled Dec 6, 2023 · #D-0125-2024
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 Dru...
Hazard
Class III — low health risk
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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 Classification: Class III Distribution: Nationwide in the USA
Product details
- 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
- Type
- Drugs
- Manufacturer
- Fagron Compounding Services
- Model numbers
- C274-000033372
- UPCs
- —