FDA recall D-0362-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13

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-0362-2020