Drug 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
D-0483-2019
Product summary
- Firm
- Akorn Inc
- Event
- Event 81836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 30,794 bottles
- Official record key
drug-enforcement:D-0483-2019
Official wording
Reason: Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Code information: Lots: 426007 and 426008, exp 4/2020
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification