Drug Enforcement D-0142-2023

CGMP Deviations:

Status

Ongoing

Classification

Class II

Report Date

January 25, 2023

Termination Date

—

Product Information

Product description
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Product quantity
3108 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
—

Codes & Dates

Recall number
D-0142-2023
Event ID
90948
Recall initiation date
October 13, 2022
Center classification date
January 13, 2023
Code info
Lot # 1F43A, EXP 5/31/2/023
More code info
—