FDA Drug Recalls

Recalls / Class II

Class IID-0376-2020

Product

CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

Affected lot / code info
Lot #: 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Altaire Pharmaceuticals, Inc.
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
311 W Ln, PO Box 849, Aquebogue, New York 11931-0849

Distribution

Quantity
531,936 units
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2019-07-02
FDA classified
2019-11-15
Posted by FDA
2019-11-27
Status
Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0376-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.