Recalls / Class II

Class IID-0133-2023

Product

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

Affected lot / code info

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

Why it was recalled

CGMP Deviations:

Recalling firm

Firm

Akorn, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278

Distribution

Quantity

1,164,171 tubes

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2022-10-13

FDA classified

2023-01-13

Posted by FDA

2023-01-25

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0133-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.