Is Your Medicine The Real Deal?

When Leslie-Ann Lescarbeau saw the sales pitch from a pharmacy called Med4Home on the Internet and TV in 2004, she couldn't resist signing up. Med4Home promised to deliver her medications right to her door and file her Medicare claims for her. Lescarbeau, 50, suffers from asthma and other lung problems and sometimes uses a wheelchair. But what Med4Home actually sent her, she believes, were reformulated versions of the brand-name medicines she was supposed to take. One of the drugs even allegedly contained alcohol, a known lung irritant. After Lescarbeau made several harrowing trips to the ER, struggling to breathe, a doctor discovered the Med4Home drugs and ordered her to switch pharmacies. "I did not see anything on Med4Home's Web site that said I wouldn't be getting the real thing," says Lescarbeau, a nondenominational Christian pastor who lives in Middletown, Conn.

Now Med4Home's parent company, home health-care provider Lincare Holdings Inc., (LNCR ) is in the crosshairs of the Food & Drug Administration. In August the agency sent a warning letter to another Lincare affiliate that makes the drugs Med4Home delivers. The FDA blasted the affiliate, Reliant Pharmacy Services, for making drugs at "ineffective or dangerous dosage levels," maintaining poor quality-control practices, and in some cases sending patients non-FDA-approved copies of commercially available drugs without getting clearance from their physicians. The letter, obtained by BusinessWeek under the Freedom of Information Act, warns that if the company continues these practices, the FDA "may take immediate enforcement action, including seizure and injunction, against [the company], its products, and its principals." A spokesman for Lincare repeatedly declined to comment.