← FDA ENFORCEMENT
D-0221-2026Class II

Fagron Compounding Services

Recalling firm
Fagron Compounding Services
Product type
Drug
Status
Ongoing
Report date
2025-12-17
Distribution
U.S. Nationwide.
Firm state
KS
Product quantity
2980 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Incorrect Product Formulation

Product description

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

Code / lot info

Lot#: C274-000047958; Exp. December 19, 2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.