D-0483-2019 Class III Terminated
FDA drug recall D-0483-2019 was initiated by Akorn Inc on Dec 20, 2018 and is designated Class III. Reason for recall: Failed Stability Specifications: out of specification results for opalescence at 7 month stability study. The recall status is terminated (terminated Nov 6, 2020). Affected quantity: 30,794 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 20, 2019
- Initiation Date
- Dec 20, 2018
- Termination Date
- Nov 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,794 bottles
Product Description
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
Reason for Recall
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lots: 426007 and 426008, exp 4/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0483-2019
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026