D-0149-2023 Class II Ongoing
FDA drug recall D-0149-2023 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: 173,928 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Oct 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173,928 bottles
Product Description
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
Reason for Recall
CGMP Deviations:
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0149-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026