FDA recall D-0366-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49

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-0366-2020