FDA-Drug2016-10-19Class II
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
Leiter's Compounding
Hazard
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Sold states
Nationwide
Affected count
76,315 total units, all products
Manufactured in
17 Great Oaks Blvd, N/A, San Jose, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2017Don't want to check this manually?
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