Just yesterday we reported about AAP Pharmaceutical Drug Plants that are having quality control issues. However, this does not seem to be an isolated issue. According to MSNBC, we found another plant having issues, this time instead of bugs being found in drug vials, there are tainted alcohol wipes involved. And, these wipes have led to hundreds of sickened patients, as well as the death of a little 2 year old boy named Harrison Kothari.
The contamination of the wipes was made public, on Jan. 6, 2011 when the FDA issued a recall for Triad Group’s alcohol prep pads, alcohol swabs, and alcohol swabsticks that are used to disinfect prior to an injection. The recall was initiated due to concerns about potential contamination of the products with Bacillus cereus.
Triad’s recall covered all lots of its alcohol prep pads, wipes and swabs, totaling perhaps hundreds of millions of products sold in the U.S., Canada and Europe.
But is this a new problem? Documents suggest not.
Government documents obtained by msnbc.com show that FDA officials expressed concerns following visits to the Triad plant of Hartland, Wis. from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.
The documents did not mention specific contamination of the swabs or pads with Bacillus cereus. But, stated “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.
So, ultimately there may be several parties at fault for the little life of Harrison.
The FDA inspection reports were first completed 16 months before 2-year-old Harrison Kothari developed meningitis caused by Bacillus cereus bacteria. The child was recovering well after the removal of a benign cyst and was scheduled to go home the day before the fatal infection flared up. He died on Dec. 1, 2010.
More than 50 people have now contacted lawyers representing Sandra and Shanoop Kothari, who are suing the Triad Group for gross negligence in their son’s Dec. 1, 2010 death. And, another 100 reports of problems have been logged by the FDA since the Jan. recall of the Triad products because of potential contamination with the bacteria Bacillus cereus, an agency spokesman said.
“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.
“This is confirming the Kotharis’ worst nightmare — that this was far more widespread than they thought,” said Perdue.
H&P Industries, which does business as the Triad Group, is among the largest providers in the U.S. of generic medical products often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens.