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Mallinckrodt Issues Voluntary Recall of Technetium Tc-99m Generators

CORAR Generator Press Release (12/14/2005)

On November 18 Mallinckrodt issued a voluntary product recall on its Ultra-TechneKow(R) DTE generator (Technetium Tc-99m generator) with a request for immediate discontinuation of use of any of its generators in the market. This recall came as the result of a routine sterility assurance process revalidation.

Mallinckrodt has indicated that patient doses should not be formulated from any of its generators and that generator availability will be affected for a minimum of six weeks. No adverse events related to the recall have been reported.

Click on the links below to access the letters and a question and answer sheet sent by Mallinckrodt to its customers.

As we learn more we will use e-mail and our Web site to communicate to you any further news or developments.

Mallinckrodt Letter to Customers (pdf)
Mallinckrodt Customer FAQs (pdf)
Mallinckrodt Generator Recall Fax Letter (pdf)

[added November 22, 2005]

The Council on Radionuclides and Radiopharmaceuticals (CORAR)-an association comprised of 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:

November 21, 2005

NOTICE TO THE NUCLEAR MEDICINE COMMUNITY

As you may know, Mallinckrodt has issued a voluntary product recall of its Ultra-TechneKow® DTE Generators due to issues arising from a routine sterility assurance process revalidation. Mallinckrodt has indicated that their generator supply will be affected for a period of four to six weeks. To date, no adverse events have been reported from these products in the field.

In the wake of this development the industry is cooperating, as appropriate, to meet the overall demand for Technetium-99m (Tc-99m) generators in North America and related patient unit doses, provided through radiopharmacy distributors, which use this critical isotope. This includes production scale up for both Tc-99m generators and Molybdenum-99, the raw material isotope. At this time, it is anticipated most of the market shortages for Tc-99m generators and Tc-99m unit doses should be met beginning Monday, November 28. Varying degrees of market shortages of Tc-99m will continue to be experienced during Thanksgiving week, although unit dose shortages should be reduced as the week progresses as additional supply of Tc-99m generators is manufactured by Bristol-Myers Squibb Medical Imaging.

The possibility exists for sporadic shortages to still occur over the next month or so, due to one company not being able to assure total supply of market demand. With only one manufacturing site, other influencing factors, such as winter weather, may affect availability of Tc-99m generators and Tc-99m unit doses.

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.

BMS Letter to Customers 11/21/05 (pdf)
CORAR Press Release 11/21/05 (pdf)

If you have any questions, please contact Lynne Fairobent, AAPM's Manager of Legislative and Regulatory Affairs at 301-209-3364 or via email: lynne@aapm.org.