Four federal agencies stopped the sale of a chemical disinfectant for medical instruments yesterday, saying it doesn't always kill diseases that can be passed from one patient to another.
Sporicidin, a chemical manufactured by a Rockville company and distributed from a Baltimore warehouse, has been used for 14 years in hospitals, dentists' offices and veterinary clinics.
Yesterday, the federal government stopped the sale and distribution and fined Sporicidin International $420,000 for making false claims about the product on the label. In addition, a preliminary injunction has been issued to stop false advertising claims.
The Food and Drug Administration, the Environmental Protection Agency, the Federal Trade Commission and the U.S. attorney's office took the action after FDA tests showed the chemical was ineffective against fungal infections and other infections such as tuberculosis and hepatitis. However, there is no risk the virus that causes AIDS was transmitted because Sporicidin and most other disinfectants will destroy it.
"We are absolutely baffled," said Robert Schattner, owner and president of Sporicidin International.
Sporicidin International stopped manufacture and distribution of the chemical, he said, "to vigorously contest these actions and comply with the agency demands."
While the Centers for Disease Control in Atlanta have no reports of illnesses caused by the use of Sporicidin, an FDA official acknowledged that it would be difficult to trace the transmission of illness to the lack of disinfection.
U.S. marshals went to a distribution warehouse at Point Breeze in Baltimore to seize the products yesterday but found none at the time, according to FDA officials. The agency is telling Sporicidin customers not to use the product.