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View Full Version : Check your alcohol 'medical wipes' if you have any ~ can be deadly



MNeagle
28th March 2011, 01:28 PM
FDA asks maker of tainted wipes to stop production
Voluntary move follows a new, intense investigation at Wis. medical supply firm


The federal Food and Drug Administration is asking a Wisconsin firm tied to infections and death blamed on contaminated medical wipes to voluntarily stop making and distributing its drug products, msnbc.com has learned.

The move is aimed at halting operations at H&P Industries Inc., which does business as the Triad Group of Hartland, Wis., said Michael C. Rogers, the FDA's acting director of the Office of Regional Operations. It comes at the conclusion of an intense, week-long inspection that concluded Monday, Rogers said.

"We have evidence that shows this firm made and distributed products with a variety of opportunistic pathogens," Rogers said.

A spokeswoman for H&P Industries Inc. said firm officials were reviewing the request and had no immediate comment.

The cease-and-desist request follows a series of msnbc.com news reports about inspections at the Triad Group plant and massive recalls of alcohol prep wipes, povidone iodine prep wipes and lubricating jelly all suspected of bacterial contamination.

The alcohol wipes, which were recalled for potential contamination with the bacteria Bacillus cereus, have been blamed for several serious infections and the death of a 2-year-old boy in Houston.

This is the strongest action that the FDA has taken in the case, but involves no mandatory changes. The move does not rise to the level of a court order, in which the agency could go to court to force the firm to stop its operations.

Rogers said the agency has not yet concluded its investigation of the H&P Industries situation or made a final determination that could lead to sanctions including court action. He said the interim move is aimed at protecting public safety. He wouldn't say exactly what violations the new investigation revealed, but said that recalls would be issued for any products that jeopardized public health.

"We're still evaluating all of the information," he said.

Firm overhauls top management
The FDA's move comes days after H&P Industries officials vowed to overhaul its management and revamp quality control and manufacturing processes in the wake of government inspections, new documents show.

David Haertle and Eric Haertle, two brothers who own H&P Industries Inc., will step away from daily operations of the 30-year-old family firm, according to documents posted by the FDA. A new chief operating officer will be appointed, the new documents indicate.

However, David Haertle, 48, will continue to serve as manager of the Triad Group and Eric Haertle, 44, will take over as president of H&P Industries.

In the midst of questions about product safety, both men have put their Wisconsin homes up for sale. David Haertle is asking $2.6 million for a 5-bedroom, 6-bathroom lakeside home in Oconomowoc Lake, Wis. Eric Haertle is seeking $789,900 for a 4-bedroom, 4-bathroom “executive home” in Delafield, Wis., according to the listing.

H&P Industries is pledging to hire a new quality control manager, validate the processes it uses to ensure sterility and test for contamination, and outsource its tests to an independent microbiology lab.

“Systemic failures have been noted,” Eric Haertle wrote in a 28-page response to an FDA inspection known as a Form 483. The Jan. 28 document was made public last week.

The H&P Industries changes are aimed at addressing bacterial contamination that prompted massive recalls of alcohol prep pads and iodine prep pads. The alcohol pads were recalled Jan. 3 after they were confirmed to be tainted with bacteria Bacillus cereus and blamed for serious infections at a Colorado children’s hospital and the death of a 2-year-old Houston boy.

The iodine prep pads were recalled March 16 after they were found to be contaminated with the bacteria Elizabethkingia meningoseptica, which has been linked to meningitis in newborns and flesh-eating bacteria disease.

Families of victims 'insulted'
Despite promises of change, the lawyer who represents the family of the dead child, Harrison Kothari, said that proposed improvements are superficial at best.

“The idea that having one brother leave the president position so that another brother can take it over and that this flip will fix the operational ethic of this company is comical,” said Jim Perdue Jr. “It should insult the FDA as much as it insults the patients who trusted these products.”

This isn't the first time that H&P Industries has pledged to correct fundamental problems with sterilization and contamination at the Wisconsin plant that produces a wide range of intimate care products sold under the private brands of grocery and drug stores.

Previous FDA inspections found issues with basic validation of the processes used to ensure sterility and stability of several Triad products, including lubricating jelly used in vaginal exams and alcohol swab sticks and pads.

FDA documents dating to 2009 show that the firm promised to fix problems then, too.

“We have reviewed all processes and have laid out a plan to complete the additions to and/or upgrades of cleaning, maintenance and sanitizing procedures to be completed by June 1, 2010,” the company stated in an Aug. 17, 2009 letter to Marie Fadden, an FDA consumer safety officer.

Four months after this deadline, in October 2010, a 10-year-old boy with leukemia developed a life-threatening infection caused by Bacillus cereus traced to Triad alcohol pads. Doctors at The Children’s Hospital in Aurora, Colo., detected the bacteria in 40 of 60 Triad pads tested from eight of 10 lots .

Then, two months later, on Dec. 1, 2010, Harrison Kothari died of bacterial meningitis caused by Bacillus cereus, doctors say. His parents blame the Triad wipes used at the hospital that cared for him.

http://www.msnbc.msn.com/id/42275174

Down1
28th March 2011, 02:38 PM
Good to know the FDA is on the case !
We can mark this case possibly solved by 2023.

No brands that are affected are mentioned, they just say "private label" brands. Kind of a downer.
I have just bought some stuff by J&J, but I believe I am safe till I read otherwise.

Just thinking MNeagle, but maybe this should go in the general forum.
People buying this stuff from "Dollar Store" type locations might be affected.
They might not come down here.
Even for me many days it's hard to get to find time to visit this sub-forum.

Down1
30th March 2011, 04:42 PM
Found some info on a couple brands.

. They were sold under the Triad brand name, as well as under a variety of other labels, including CVS, Walgreens and Cardinal Health.
http://www.aboutlawsuits.com/triad-shutdown-request-17170/

Seems a lot of people with MS and diabetes have suffered because of this.

Antonio
30th March 2011, 04:44 PM
How can germs and viruses survive in 70% alcohol and iodine?

Down1
30th March 2011, 04:55 PM
Unknown if this is accurate info. It was in the comment section here.
http://www.aboutlawsuits.com/alcohol-swab-recall-15405/

B. Cereus can form spores, which would not necessarily be killed by 70% alcohol. These spores can also resist heat very well too, so they can be nasty little buggers. Throw out the product.

mightymanx
30th March 2011, 06:44 PM
How can germs and viruses survive in 70% alcohol and iodine?


Google MRSA and read till you can't sleep due to germphobia.

sirgonzo420
30th March 2011, 08:08 PM
How can germs and viruses survive in 70% alcohol and iodine?


Google MRSA and read till you can't sleep due to germphobia.




Don't tell Antonio that! I remember reading a post of his where he said a fag brushed his arm or something so he had to run to the nearest drugstore and clean his arm with alcohol.


lol


I don't care what anyone else thinks of Antonio, I think he's swell!

;D

willie pete
30th March 2011, 08:15 PM
How can germs and viruses survive in 70% alcohol and iodine?



alcohol is a bacteriostatic not a bacteriocide

Antonio
30th March 2011, 08:18 PM
How can germs and viruses survive in 70% alcohol and iodine?


Google MRSA and read till you can't sleep due to germphobia.




Don't tell Antonio that! I remember reading a post of his where he said a fag brushed his arm or something so he had to run to the nearest drugstore and clean his arm with alcohol.


lol


I don't care what anyone else thinks of Antonio, I think he's swell!

;D


I sure did back in 1991 or so. At that time one could see fags all over Manhattan with big fuckin Kaposhi sarcomas on their necks, there was such dense wheelchair traffic of dying fags that one felt like taking a shower in pure alcohol after being accidentally touched by them.