Eye drops recalled over sterility concerns
Altaire Pharmaceuticals, Inc., is recalling the Over-the-Counter (OTC) drug products and lots sold by Natural Ophthalmics and TRP Company, according to the U.S. Food and Drug Administration.
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 inventory of the distributors and retail outlets.
Source: U.S. Food and Drug Administration.
For a full list of the affected products, click here.