D-0133-2023 Class II Ongoing
FDA drug recall D-0133-2023 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: 1,164,171 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Oct 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,164,171 tubes
Product Description
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
Reason for Recall
CGMP Deviations:
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 0A08B, EXP 12/31/2022; 0B63A, EXP 1/31/2023; 0C72A, EXP 2/28/2023; 0D14A, 0D19A, EXP 3/31/2023; 0F54A, EXP 5/31/2023; 0G80B, 0G09B, 0G97A, EXP 6/30/2023; 0J78A, EXP 8/31/2023; 0K23A, EXP 9/30/2023; 0L64A, EXP 10/31/2023;1B29A, EXP 1/31/2024; 1C59A, 1C53A, 1C72A,1C78A, EXP 2/29/2024; 1D87A, 1D89A, EXP 3/31/2024; 1G59A, 1G59B, EXP 6/30/2024; 1K60A, EXP 9/30/2024; 1J57A, EXP 8/31/2024; 1H86A, EXP 7/31/2024; 1K75A, EXP 9/30/2024; 1L12A, EXP 10/31/2024; 1M22A, EXP 11/30/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0133-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026