FDA recall D-0483-2019

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.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-12-20

Report date

2019-02-20

Termination date

2020-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0483-2019