Molecular Imaging News
December 15, 2005
CORAR Update on Voluntary Product Recall of Mallinckrodt’s Ultra-TechneKow® DTE Generator
The Council on Radionuclides and Radiopharmaceuticals (CORAR) - an association comprising companies in the United States and Canada who manufacture and distribute radiopharmaceuticals, sealed sources, and radionuclides primarily used in medicine and life science research - has released the following information:
December 14, 2005
UPDATE FOR THE NUCLEAR MEDICINE COMMUNITYCORAR wants to update the nuclear medicine community on the voluntary product recall of Mallinckrodt’s Ultra-TechneKow® DTE Generator, and the industry’s combined efforts to cover the needs of the community.
While the industry experienced some localized shortages of Technetium-99m (Tc-99m) the week following the November 18, 2005 recall announcement, Bristol-Myers Squibb Medical Imaging has successfully scaled up their Tc-99m generator production allowing the industry to better cover the nuclear medicine community’s needs.
Mallinckrodt has estimated a return to generator production around March 31, 2006. The timeline is based upon procurement of certain equipment improvements and restart processes. The industry continues to cooperate, as appropriate, to meet the overall demand for Tc-99m generators in North America and related patient unit doses provided through radiopharmacy distributors. While we do not currently anticipate any appreciable difficulty in meeting industry demand for Technetium-99m (Tc-99m) going forward, the possibility still exists for sporadic shortages due to unforeseen circumstances, such as winter weather, or other factors.
Should there be questions related to how this dynamic and evolving situation affects your facility, please contact the appropriate company sales representative for further specifics. CORAR will provide additional information, related to market supply of Tc-99m generators and Tc-99m unit doses, as it may develop.
Thank you for your understanding and assistance.