Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2 recalled over sterility concerns

Recall date

September 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Leiter's Compounding recalls Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), i…

Recall number

D-0013-2017

FDA classification

Class II

Brand / firm

Leiter's Compounding

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38