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

Recall Number: D-0153-2023

Firm: Akorn, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20230125

Initiation Date: 20221013

Termination Date:

CGMP Deviations:

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