FDA recall D-0429-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10

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-0429-2020