FDA recall D-0423-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13

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-0423-2020