Class III
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- December 20, 2018
- Posted
- February 20, 2019
- Recall Number
- D-0483-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 30,794 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lots: 426007 and 426008, exp 4/2020
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