Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lots: 426007 and 426008, exp 4/2020
Why it was recalled
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 30,794 bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2018-12-20
- FDA classified
- 2019-02-08
- Posted by FDA
- 2019-02-20
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0483-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.