Akorn Inc recalls COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx
Recalled February 20, 2019 · FDA recall D-0483-2019 · Akorn
Hazard
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study. · FDA Class III
Units
30,794 bottles
Sold at
Nationwide USA and Puerto Rico
Description
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Product
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
Manufacturer(s)
Akorn Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →