PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 25, 2023 Initiated: October 13, 2022 #D-0149-2023

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:

Details

Recalling Firm
Akorn, Inc.
Units Affected
173,928 bottles
Distribution
Nationwide in the USA
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 173,928 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-0149-2023.