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
Reason for recall: Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Recall initiated: 20181220
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated