Akorn, Inc.: Drug Recall

Recall #D-0153-2023 · 10/13/2022

Class II: Risk

Recall Details

Recall Number
D-0153-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Akorn, Inc.
Status
Ongoing
Date Initiated
10/13/2022
Location
Gurnee, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
267,678 bottles

Reason for Recall

CGMP Deviations:

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

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.