FDA-Drug2019-09-18Class II
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Compounded Solutions in Pharmacy
Hazard
Lack of Processing Controls:
Sold states
Product was dispensed to patients
Affected count
a) 4x5 ml, b) 1x10 ml bottles
Manufactured in
810 Main St, Monroe, CT, United States
Products
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1855-2019Don't want to check this manually?
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