Altaire Pharmaceuticals, Inc., announces that it is voluntarily recalling the prescription drug products and lots, within expiry, distributed during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed. No other lots are being recalled.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including sterility testing, for the products.