FDA Recall D-375-2014

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.

Lot / code: 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.

Quantity: 363,746 bottles.

Reason for recall

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.

Recall record

Recall number

D-375-2014

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution

Nationwide

Recall initiated

2013-09-06

Classified by FDA Center

2013-12-18

FDA published

2013-12-25

Terminated

2014-09-30

Recalling firm

Altaire Pharmaceuticals, Inc.

Firm location

Aquebogue, NY