FDA recall D-0433-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S.A. Nationwide

Key facts

Status
Completed
Initiation date
2019-07-02
Report date
2019-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aquebogue, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2020