Altaire Pharmaceuticals, Inc., recalled nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, 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. The preservative may not be effective throughout the usage period to the expiration date.
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. Altaire confirmed that all lots of the product were sterile at the time of release and that the preservative was effective when challenged against the USP Preservative Effectiveness Test. Altaire confirmed that its production facility is not the source of any reported contaminants.
The product is known generically as Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution. This product has been labeled for CVS, Target and Wal-Mart 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, 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 specific lots are affected. The recall is limited to the product in the 30 mL size.
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 recalled lots were distributed between February 2012 and April 2013. The product was sold nationwide at retail stores.
Altaire Pharmaceuticals 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.
See the Recall
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