Tainted Alcohol Wipes. Tainted and infected alcohol wipes is being blamed for the death of a 2-year-old boy and the FDA knew all about it. The Houston boy died from a rare infection that has prompted a recall of tens of millions of pads and swabs.
At the same time, government documents obtained by msnbc.com showed that federal Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there’s no record that the FDA sent warning letters typically used to force firms to comply.
In the last week, more than 50 people have contacted lawyers representing Sandra and Shanoop Kothari, who are suing the Triad Group for gross negligence in their son’s Dec. 1, 2010 death.
“We’re seeing a wide spectrum of complaints,” said Jim M. Perdue Jr.,the lawyer representing the Kothari family. Reported injuries range from superficial skin infections to serious complications, and even one claim of another death. None of the new infections has been confirmed, Perdue added.
Another 100 reports of problems with alcohol prep pads have been logged by the FDA since the Jan. 5 recall of Triad products because of potential contamination with the bacteria Bacillus cereus, an agency spokesman said.
And a Tennessee man has filed his own $30 million lawsuit against Triad, claiming he developed an infection from Bacillus cereus from the wipes and had to undergo open-heart surgery as a result.