cGMPs

Altaire Recalls Moldy Eye Drops

Source: pharmamanufacturing.com

Sep 12, 2013

Fda.gov

Altaire Pharmaceuticals, Inc. is voluntarily recalling a total of nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level due to complaints of mold found in the 30 mL bottles after use.

 

There have been no reports of adverse effects to consumers so far, however, 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.