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Tuesday, September 24, 2013

FDA Eye Drop Recall

This is why we recommend non-generic products for our patients, and only sell high quality, brand- names in The Optical Gallery at The Eye Associates.

NOTICE from www.FDA.gov: RECALL of OTC artificial tear by Altaire Pharmaceuticals

Altaire Pharmaceuticals issued a voluntary nationwide recall of 9 lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, a non-prescription (OTC) drug product used to relieve dryness of the eye. There have been no reports of adverse effects to consumers so far. However, due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative have prompted the recall. A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection.

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

Only 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. The product was sold nationwide at retail stores. Consumers who have the product with any of the lot numbers listed above should stop use of the product imme

Altaire Pharmaceuticals is initiating the recall as a precautionary measure.

To learn more, visit the FDA website at:  http://www.fda.gov/Safety/Recalls/ucm367559.htm
diately and return it to the place of purchase.

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