42 drug companies received FDA warnings since 2009

Courtesy of USA Today

At least 43 drug factories supplying medication to thousands of U.S. consumers have received government warnings in recent months for failing to correct shoddy manufacturing practices that may have exposed patients to health risks. Violations serious enough to prompt warning letters from the U.S. Food and Drug Administration include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick. The 43 warning letters, issued since January 2009, reflect only some of the most serious manufacturing violations the FDA finds during facility inspections.

Among violations identified in FDA warning letters:

• Two of the three companies that supply propofol, an injectable drug used during surgeries, had safety recalls. In July, Teva Pharmaceuticals recalled propofol made in California after 41 patients developed post-operative fever and other symptoms the company said may indicate exposure to bacterial toxins. In November and March, a North Carolina plant run by Hospira recalled propofol because of contamination with steel particles.

• An Illinois plant run by Balchem that makes calcium carbonate, an ingredient in antacids and a menopause medication, sent out products made with water the plant knew was contaminated with coliform bacteria.

• A Massachusetts plant run by Braintree Laboratories failed to properly investigate 21 consumer complaints of bug parts or spiders in five of its medicine products, according to the May warning letter.

• Several species of bacteria were found on equipment at a Puerto Rico plant that makes drugs and cosmetics for Procter & Gamble, according to an April 2009 warning letter. The letter also cited the company for failing to investigate 198 complaints in the previous year alleging health problems associated with a Vicks Sinex product made there. In November, the company separately recalled Vicks Sinex nasal spray made in Germany because of bacterial contamination.