FDA Drug Recalls

Recalls / Class II

Class IID-0489-2020

Product

Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7

Affected lot / code info
Lot #: 16192, Exp 7/19; 16203, Exp 7/19; 16242, Exp 9/19; 16280, Exp 10/19; 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, Exp 1/20; 17012, Exp 1/20; 17051, Exp 2/20; 17130, Exp 04/20; 17147, Exp 05/20

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
N/A
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-0489-2020. 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