FDAFDA · Food and drugs·Recall number D-0483-2019
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
Published February 20, 2019 · Recall initiated: December 20, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lots: 426007 and 426008, exp 4/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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