PlainRecalls
FDA Drug Moderate Class II Ongoing

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

Reported: January 25, 2023 Initiated: October 13, 2022 #D-0153-2023

Product Description

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

Reason for Recall

CGMP Deviations:

Details

Recalling Firm
Akorn, Inc.
Units Affected
267,678 bottles
Distribution
Nationwide in the USA
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12. Recalled by Akorn, Inc.. Units affected: 267,678 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-0153-2023.