Warning
Fagron Compounding Services Recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0221-2026Drug / Pharmaceutical
Fagron Compounding Services Recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2
Fagron Compounding Services · Class II — Moderate Risk
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
Reason for Recall
Incorrect Product Formulation
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database