Missouriwatcher
Editor, Senior Moderator
September 06, 2013 ? Aqueboque, NY, Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. 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 after use and handling of the product by consumers 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. It has been confirmed by Altaire that all lots of product were sterile at the time of release, and that the preservative was effective when challenged against the USP Preservative Effectiveness Test. It has also been confirmed by Altaire that its production facility is not the source of any reported contaminants.
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.
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. 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.
Altaire Pharmaceuticals is initiating the recall as a precautionary measure. Altaire takes its mission of consumer care and providing quality products very seriously. The company has reformulated the product with an enhanced preservative system. All lots of the product in the 30 mL size identified with lot numbers beginning with 13 (i.e. 13000) have been made with the enhanced preservative system.
http://www.fda.gov/Safety/Recalls/ucm367559.htm
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. It has been confirmed by Altaire that all lots of product were sterile at the time of release, and that the preservative was effective when challenged against the USP Preservative Effectiveness Test. It has also been confirmed by Altaire that its production facility is not the source of any reported contaminants.
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.
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. 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.
Altaire Pharmaceuticals is initiating the recall as a precautionary measure. Altaire takes its mission of consumer care and providing quality products very seriously. The company has reformulated the product with an enhanced preservative system. All lots of the product in the 30 mL size identified with lot numbers beginning with 13 (i.e. 13000) have been made with the enhanced preservative system.
http://www.fda.gov/Safety/Recalls/ucm367559.htm