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

FDA recall notice · announced February 20, 2019 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lots: 426007 and 426008, exp 4/2020
Quantity: 30,794 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0483-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.