PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 25, 2023 Initiated: October 13, 2022 #D-0134-2023

Product Description

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 for Recall

CGMP Deviations:

Details

Recalling Firm
Akorn, Inc.
Units Affected
967,075 bottles
Distribution
Nationwide in the USA
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 967,075 bottles.
Why was this product recalled?
CGMP Deviations:
Which agency issued this recall?
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0134-2023.