Leiter's Compounding recalls Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in
Recalled October 19, 2016 · FDA recall D-0013-2017 · Leiter's Compounding
Hazard
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters · FDA Class II
Units
76,315 total units, all products
Sold at
Nationwide
Description
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Product
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
Manufacturer(s)
Leiter's Compounding
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →