Company Announcement Date: July 16, 2019
FDA Publish Date: July 16, 2019
Product Type: Drugs
Reason for Announcement: Due to lack of sterility assurance
Company Name: Altaire Pharmaceuticals Inc.
Brand Name: Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige
Product Description: Over-The-Counter Ophthalmic Products
Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., during the time period as indicated in the tables below. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets.
Product Description: Clear Eyes Redness Relief
UPC#: 6-78112-25415 – Product Size: 15 mL
UPC#: 6-78112-65920 – Product Size: 15 mL
UPC#: 6-78112-66577 – Product Size: 15 mL