Leiter's Compounding recalls Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Comp
Recalled October 19, 2016 · FDA recall D-0010-2017 · 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
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Manufacturer(s)
Leiter's Compounding
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →