Drug Enforcement D-0153-2023

CGMP Deviations:

Status

Ongoing

Classification

Class II

Report Date

January 25, 2023

Termination Date

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Product Information

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
Product quantity
267,678 bottles
Reason for recall
CGMP Deviations:
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Akorn, Inc.
Address
5605 Centerpoint Ct Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0153-2023
Event ID
90948
Recall initiation date
October 13, 2022
Center classification date
January 13, 2023
Code info
Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023
More code info
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