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Fagron Compounding Services: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophtha

DrugsSource: FDA (drug) · Date: 2025-12-17

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Fagron Compounding Services
Product
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Reason / hazard
Incorrect Product Formulation
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide.
Recall initiated
2025-11-20
Code info
Lot#: C274-000047958; Exp. December 19, 2025
Product quantity
2980 syringes
Voluntary mandated
Voluntary: Firm initiated
City
Wichita
State
KS
Country
United States
Event id
98040
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