FDA recall D-0373-2020

Altaire Pharmaceuticals, Inc. · Class II · drug

Product

CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

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-0373-2020