D-0137-2023 Class II Ongoing
FDA drug recall D-0137-2023 was initiated by Akorn, Inc. on Oct 13, 2022 and is designated Class II. Reason for recall: CGMP Deviations: The recall status is ongoing. Affected quantity: 188,550 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Oct 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188,550 bottles
Product Description
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
Reason for Recall
CGMP Deviations:
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 0G75A, 0G12A, EXP 6/30/2023; 0H50A, EXP 7/31/2023; 0J88A, EXP 8/31/2023; 1D98A, EXP 3/31/2024; 1E31A, EXP 4/30/2024; 1D97A, EXP 3/31/2024; 1H14A, EXP 7/31/2024;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0137-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026