Covidien unit faces federal inspection

Federal regulators are inspecting the Hazelwood-based Mallinckrodt unit of Covidien Inc. after learning of problems with generators it sold for use in nuclear medicine.

The Nuclear Regulatory Commission said Wednesday that the generators were producing doses containing a nuclear isotope, molybdenum-99, that should have been contained within the units.

Molybdenum-99 decays to produce technetium-99m, an isotope that is released from the generator and mixed with other pharmaceutical compounds; it then is administered to patients in order to illuminate tumors, or the heart, in diagnostic imaging.

Mallinckrodt received information between Jan. 11 and Jan. 31 that the problem occurred in more than 100 generators, the NRC said. The company’s labeling directs nuclear pharmacists to test the makeup of each dose as it is drawn from the generator.

It was not immediately clear whether any improper doses had reached patients.

“Covidien has already taken actions it believes will help to mitigate this issue,” said spokeswoman JoAnna Schooler, in an e-mailed response to questions. “The company is cooperating fully with the Nuclear Regulatory Commission.”

The NRC said in a statement it has dispatched an inspection team “to evaluate the event (and) the company’s response to the event.”

Once the inspection is complete, the agency will issue a report within 30 to 45 days. It will be available online at www.nrc.gov/reading-rm/adams/web-based.html.