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Home › Prescription medicine › Fagron Compounding Services — Tropicamide 1%…
Do not stop taking this without speaking to your pharmacist or doctor.
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
The Recall Registry rates this labelling issue — FDA Class III: unlikely to cause harm.
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Fagron Compounding Services
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
Nationwide in the USA
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Fagron Compounding Services — 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 &”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine