Molecular Imaging News
March 23, 2006
Mallinckrodt To Restart Ultra-TechneKow Technetium Generator Production, Shipment
Mallinckrodt will restart manufacturing and shipment of its Ultra-TechneKow Technetium Generator, effective April 5, according to a March 23 letter to its customers. The company voluntarily recalled the generator on November 19, 2005, as a result of issues identified during a routine sterility assurance process revalidation.
"We have worked aggressively to implement highly effective quality assurance processes," said Steve Hanley, Mallinckrodt president. "Improvements to our manufacturing processes and environmental monitoring systems support our confidence in bringing a high quality product back to market and should help to ensure a consistent supply into the future," he says in the letter.
During the period of recall, other companies, including Bristol-Myers Squibb Medical Imaging, cooperated to to meet the demand for Tc-99m generators in North America and related patient unit doses provided through radiopharmacy distributors.