Recalls / Class I

Class ID-375-2014

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0.

Affected lot / code info: Lot #: 11440, Exp 09/13, labeled for CVS; 11441, Exp 09/13, labeled for CVS; 12042, Exp 01/14, labeled for CVS and Wal-Mart ; 12103, Exp 02/15, labeled for Wal-Mart; 12203, Exp 05/15, labeled for CVS and Wal-Mart; 12207, Exp 05/15, labeled for Wal-Mart; 12293, Exp 08/15, labeled for Wal-Mart; 12352, Exp 09/15, labeled for CVS and Target; and 12356, Exp 09/15, labeled for CVS and Target.

Why it was recalled

Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.

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 West Lane, P.O. Box 849, Aquebogue, New York 11931-0849

Distribution

Quantity: 363,746 bottles.
Distribution pattern: Nationwide

Timeline

Recall initiated: 2013-09-06
FDA classified: 2013-12-18
Posted by FDA: 2013-12-25
Terminated: 2014-09-30
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-375-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.