FDA recall D-0717-2022

Akorn, Inc. · Class II · drug

Product

TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within theUSA

Key facts

Status: Terminated
Initiation date: 2021-09-08
Report date: 2022-03-30
Termination date: 2023-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0717-2022