FDA Drug Recalls

Recalls / Class II

Class IID-0372-2020

Product

Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)

Affected lot / code info
Lot #: 17290, Exp 09/19; 19011, Exp 01/21; 18052, Exp 02/20; 18266, Exp 10/20; 18178, Exp07/20; 17385, Exp 12/19

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
17,613 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-0372-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.