FDA Drug recall D-0134-2023
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, In…
- FDA Drug
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, In… by Akorn, citing CGMP Deviations:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0134-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-13 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
Reason
CGMP Deviations:
Identifiers
| code_info | Lot: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, EXP 10/31/2022; 0M02A, 0M01A, EXP 11/30/2022; 1C81A, EXP 2/28/2023; 1D02A, 1D0…Lot: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, EXP 10/31/2022; 0M02A, 0M01A, EXP 11/30/2022; 1C81A, EXP 2/28/2023; 1D02A, 1D03A, EXP 3/31/2023; 1E10A, 1E08A, 1E23A, 1E26A, 1E25A, 1E27A, 1E33A, EXP 4/30/2023; 1F46A, EXP 5/31/2023; 1G49A, 1G50A, 1G67A, EXP 6/30/2023; 1H04A, 1H74A,1H76A, 1H05A, 1H07A, 1H15A, 1H13A, 1H95A, EXP 7/31/2023; 1J44A, 1J20A, EXP 8/31/2023; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0134-2023%22
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