Reported Dec 6, 2023 · Ongoing
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL…
Fagron Compounding Services
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fagron Compounding Services · 8710 E 34th St N · Wichita, KS · 67226-2636
Is this the product you have?
- 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
- Lot codes and dates
Lot #: C274-000033372Exp. Date 01-17-2024C274-000033764Exp. Date 02-06-2024
- Amount recalled
- 756 bottles
Where it was sold
- Nationwide
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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