Akorn Inc recalls COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, R…

Recall date

December 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0483-2019

FDA classification

Class III

Brand / firm

Akorn Inc

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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