Drug Enforcement D-0146-2023

CGMP Deviations:

Status

Ongoing

Classification

Class II

Report Date

January 25, 2023

Termination Date

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Product Information

Product description
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
Product quantity
65,006 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-0146-2023
Event ID
90948
Recall initiation date
October 13, 2022
Center classification date
January 13, 2023
Code info
Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;
More code info
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