FDA Drug Recalls

Recalls / Class II

Class IID-0399-2020

Product

Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13

Affected lot / code info
19128 05/21 19009 01/21 19003 01/21 19034 01/21 19060 02/21 19061 02/21 18252 10/20 18058 03/20 18224 09/20 18185 07/20 18152 06/20 18159 06/20 18091 04/20 18090 04/20 18069 03/20

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
2,042,136 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-0399-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls