Lincare bungles drug recall

Wednesday, April 30, 2003

KANSAS CITY, Mo. — The State Board of Pharmacy ordered a large Lincare pharmacy to stop compounding respiratory drugs in March because the company allegedly bungled a recall of contaminated drugs.

The contaminated drugs included an albuterol/ipratropium inhalant, and possibly budesonide, another compounded inhalation, said Kevin Kinkade, executive director of the pharmacy board.

The exact cause of the contamination is still under investigation, and no illness or health problems have been attributed to the drugs. That hasn’t stopped the Kansas City law firm of Monsees Miller Mayer Pressley & Amick from publishing news of the recall on its Web site.

“We are motivated by consumer safety at this juncture,” said attorney Kirk Presley. “We just figured that the more people who are aware of the scope of the recall, the better.”

As of Feb. 10, 19,000 patients had been contracted concerning the recall. Over 2,500 patients have been identified as having the suspected vials. Med 4 Home recalled only partial batches of the drugs, based on machines that filled the vials, Kinkade said.

“We believe this recall was inadequate and the entire batch should have been recalled,” Kinkade said. “In its recall to patients, they did not identify what the problem was. They did not tell them they had potentially contaminated products, only that it was a quality assurance problem.”

Lincare officials did not return phone calls.

In early March, a Missouri court issued a temporary restraining order on behalf of the pharmacy board. The order forbid Med 4 Home from compounding any respiratory drugs until the company discovered and eliminated the source of the contamination. As of early April, the restraining order was still in place. Lincare’s other respiratory pharmacies are compounding and delivering drugs to Med 4 Home patients while the restraining order is in place, say industry sources.

In a court transcript, Med 4 Home attorney Dennis Davis blamed the Missouri Board of Pharmacy for the recall problem. “It’s apparent that the Missouri Pharmacy Board has never seen necessary to give any assistance on ... how to make product retrievals or recalls of this sort,” Davis told the court.

He also stated that Med 4 Home plans to exit the compounding business because Missouri intends to require that compounding be done in a sterile lab.

“Were not resisting that decision,” Davis said. “We’re simply going to get out of that business and just sell commercially manufactured product.” HME