FDA recall D-0135-2023

Akorn, Inc. · Class II · drug

Product

Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10

Reason for recall

CGMP Deviations:

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2022-10-13
Report date: 2023-01-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0135-2023