FDA-Drug2019-02-20Class III
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
Akorn Inc
Hazard
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Sold states
Nationwide USA and Puerto Rico
Affected count
30,794 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0483-2019Don't want to check this manually?
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