Connecticut BBB, State and Federal Officials
Urge Consumers to Return Product to Retailers
Connecticut BBB is issuing an alert for consumers who use over-the-counter products for eye dryness. Altaire Pharmaceuticals, Inc. has issued a recall of nine lots of an ophthalmic solution sold at CVS pharmacies, Wal-Mart and Target stores.
The product is known generically as Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution and labeled as follows:
- Equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc.;
- Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.;
- Lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. by Target Corp.
In a news release posted on the Food and Drug Administration (FDA) website, the company says, although there have been no reports of injury to consumers, complaints of mold in some bottles of the product call into question the effectiveness after handling. Lots of the faulty preservative may cause eye infection.
The lots listed below are affected, and the recall is limited to the product in the 30 mL size:
Lot # 11440, expiration date 09/2013, labeled for CVS;
Lot # 11441, expiration date 09/2013, labeled for CVS;
Lot # 12042, expiration date 01/2014, labeled for Wal-Mart and CVS;
Lot # 12103, expiration date 02/2015, labeled for Wal-Mart;
Lot # 12203, expiration date 05/2015, labeled for Wal-Mart and CVS;
Lot # 12207, expiration date 05/2015, labeled for Wal-Mart;
Lot # 12293, expiration date 08/2015, labeled for Wal-Mart;
Lot # 12352, expiration date 09/2015, labeled for Target and CVS;
Lot # 12356, expiration date 09/2015, labeled for Target and CVS.
Lot numbers can be found printed horizontally on the side of the label and on the bottom flap of the box.
The lots listed above were distributed between February 2012 and April 2013. Adverse reactions or quality problems experienced with the use of this product may be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500
at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Submitted by Howard Schwartz, Executive Communications Director, Connecticut Better Business Bureau
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