Reported Feb 20, 2019 · Terminated
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile,…
Akorn Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn Inc · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only
- Distributed byAkorn, Inc., Lake Forest, IL
- NDC17478-605-10
- Lot codes and dates
- Lots
426007 and 426008exp 4/2020
- Lots
- Amount recalled
- 30,794 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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