March 29, 2007
In a March 28 letter to customers, Mallinckrodt announced the return to full production and shipping of their Ultra-Technekow DTE® (technetium Tc-99m generator) on Monday, April 2, for use on Tuesday, April 3. They will resume limited production of generators for their pharmacies, Latin America and Canada on Friday, March 30, and Sunday, April 1.
Mallinckrodt successfully completed their revalidation process and met all of their sterility assurance requirements. They concluded their manufacturing line is operating in a controlled state and that the sterility assurance level supports the release of the product to the field.
|3/28/2007 Mallinckrodt Letter to Customers|
|Mallinckrodt Customer Letter and FAQ Regarding Voluntary Recall|