A Rockville manufacturer of germicides used to disinfect hospital equipment has agreed not to sell products that don't do the job under a consent decree signed yesterday by the U.S. attorney's office and the U.S. Food and Drug Administration (FDA).
The decree ends the government's litigation against Sporicidin International, which was charged in a civil lawsuit in December with selling ineffective products.
Before resuming sales, the firm will have to reformulate the products the government seized when it brought the charges and gain FDA approval for their use.
Sporicidin president, Dr. Robert I. Schattner, said the company's products have never caused any hospital infections in the 14 years they have been on the market. He said Sporicidin was being singled out unfairly by the government, while competitors are being given a chance to comply with new FDA standards.
At the time of the seizure, Sporicidin had about 25 percent of the market for medical disinfectant and sterilizing solutions.
FDA Commissioner David A. Kessler called it "a bellwether case" and warned other germicide manufacturers to take note.
"The prudent company in the chemical germicide marketplace should be seeking FDA assistance now to ensure its products are effective against germs, instead of risking the scope of enforcement action experienced by Sporicidin International," Mr. Kessler said in a prepared statement.
The company is prohibited from making claims that Sporicidin Cold Sterilizing Solution or Sporicidin HD are high-level or intermediate-level disinfectants, that they have synergistic activity or contain sodium phenate until the company submits data to support those claims and receives FDA approval.
The decree affects the company's disinfectant liquid, spray and towelettes.
Dr. Curtis L. Lynch, Sporicidin's vice president and medical director, said the company's products had been approved in the past by the U.S. Environmental Protection Agency and the FDA.
Dr. Lynch said the company was surprised by the government's Dec. 13, 1991, raid of its offices because it believed its products had complied with FDA requirements.
He said the company signed the consent decree to avoid prolonged litigation and expected to recondition its products and gain approval to resume sales within the next two months.