COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL drop...
FDA Recall #D-0483-2019 — Class III — December 20, 2018
Product Description
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.
Recalling Firm
Akorn Inc — Lake Forest, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
30,794 bottles
Distribution
Nationwide USA and Puerto Rico
Code Information
Lots: 426007 and 426008, exp 4/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated