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

Recall Number: D-0483-2019

Firm: Akorn Inc

Classification: Class III

Status: Terminated

Report Date: 20190220

Initiation Date: 20181220

Termination Date: 20201106

Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.

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