March 31 (Bloomberg) -- Covidien Ltd.’s Mallinckrodt and Boehringer Ingelheim GmbH were among companies ordered by U.S. regulators to stop making and selling unapproved painkillers.

The 14 products targeted today by the Food and Drug Administration include high concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone or oxycodone. Companies must halt manufacturing within 60 days and distribution within 90 days to avoid fines, product seizure or other penalties.

This is the 10th enforcement action taken by the FDA since it began cracking down on unapproved drugs in June 2006. Many of the products have been used for years and may not meet current standards for labeling or quality. While there’s no evidence the painkillers are dangerous, consumers are better off using approved alternatives, according to the FDA.

“We don’t know if they’re safe and effective, so that poses a risk for patients,” Deborah Autor, head of the agency’s office of drug compliance, told reporters today on a conference call.

Covidien is cooperating with the regulators, said Stephen Littlejohn, a spokesman for the Hamilton, Bermuda-based company, in an e-mailed statement.

Halting Production

“We support the FDA’s efforts to reduce risk and promote patient safety,” he said. “We will comply by ceasing production and shipment within the FDA’s timelines. We are currently working out the details, which could include filing a New Drug Application.”

Boehringer licensed two of the drugs identified by the FDA’s letter to Xanodyne Laboratories Inc., a closely held drugmaker based in Newport, Kentucky, the Ingelheim, Germany- based company said in a statement. Xanodyne will be responsible for responding to the agency’s request, Boehringer said in its statement. A telephone message left for Xanodyne after regular business hours wasn’t immediately returned.

Production of a third Boehringer treatment identified in the FDA’s order was discontinued in August 2008, the company said.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: March 31, 2009 22:22 EDT