FDA Orders Alpha Blood-Product Recall

The Food and Drug Administration ordered Yoshitomi Pharmaceutical Industries Ltd.’s U.S. unit, Alpha Therapeutic Corp., to recall blood products manufactured at one of its facilities. Yoshitomi spokesman Shojiro Okuda in Tokyo said he did not know which products are being recalled, but that Alpha produces agents that help prevent infections and internal bleeding, as well as one that helps stabilize the blood pressure of burn victims. The FDA said it ordered Alpha to recall all lots of products manufactured in one particular area of the facility between Dec. 11 and June 25. “The FDA concluded that the conditions under which these biological products were manufactured . . . do not comply with good manufacturing practices,” the FDA said. The products “may have become contaminated with fungi, mold or other microorganisms,” the agency said. Alpha spokeswoman Karen White said the Los Angeles-based company, through its own inspection, found three lots of products that were contaminated with mold and notified the FDA.