D-0144-2023 Class II Ongoing

Recalled by Akorn, Inc. — Gurnee, IL

FDA drug recall D-0144-2023 was initiated by Akorn, Inc. on Oct 13, 2022 and is designated Class II. Reason for recall: CGMP Deviations: The recall status is ongoing. Affected quantity: 2,563 bottles.

Recall Details

Product Type
Drugs
Report Date
Jan 25, 2023
Initiation Date
Oct 13, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,563 bottles

Product Description

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

Reason for Recall

CGMP Deviations:

Distribution Pattern

Nationwide in the USA

Code Information

Lot, Expiry: Lots 1E28A, exp 4/30/2023

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0144-2023
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.