Drug product
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045
D-0411-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 bottles
- Official record key
drug-enforcement:D-0411-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 430358
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations