This article is more than 5 years old. Information may no longer be current.
Altaire initiating recall of ophthalmic solution
Click Here to Manage Email Alerts
Altaire Pharmaceuticals Inc. is voluntarily recalling nine lots of carboxymethylcellulose sodium 0.5% ophthalmic solution, 30 mL, at the consumer level, according to a company press release.
The recall was issued in response to concerns regarding the effectiveness of the preservative, as Altaire has received complaints of mold being found in the 30-mL bottles after use, the release said.
There have been no adverse effects to consumers reported so far, according to the release.
Altaire confirmed 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. Altaire also confirmed that its production facility is not the source of any reported contaminants, the release said.
The product, known generically as carboxymethylcellulose sodium 0.5% ophthalmic solution, is also 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) – distributed by CVS Pharmacy Inc.
- Lubricant Eye Drops for Mild to Moderate Dry Eye, sterile, 1 fl. oz. (30 mL) – distributed by Target Corp.
Lots affected by the recall are limited to 30 mL size bottles and include:
- 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
The lots listed above were distributed between February 2012 and April 2013 and sold nationwide at retail stores, the release said. All lots of the solution in the 30-mL size identified with lot numbers beginning with 13 (i.e., 13000) have been made with the enhanced preservative system.
This recall is a precautionary measure and is being conducted with the full knowledge of the U.S. Food and Drug Administration, according to the release.