Tuesday, March 29, 2011

Hepatitis C; FDA asks maker of tainted wipes to stop production

By JoNel Aleccia
Health writer

updated 3/28/2011 6:30:10 PM ET 2011-03-28T22:30:10

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.

In a statement, H&P Industries officials confirmed that they had been contacted by FDA about "manufacturing of products not covered by previous recalls." A company spokeswoman, Christy Maginn, would not say whether the firm will stop operations.

"At this time, they're still in discussions with FDA," Maginn said.

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.


The Back Story

H & P Industries, the parent company of the Triad Group, has issued a voluntary recall of all lots of providine idodine prep pads

March 19 2011

A few months ago the HCV community was alerted to a recall of prep pads from the Triad group. Some of these alcohol prep pads manufactured by H & P, triads parent company, were packaged with pegasys in the U.S . and Pegintron outside the U.S. Back in February these pads from H & P were potentially contaminated with a rare bacteria, Bacillus cereus. MSNBC had this story; USA: FDA knew of problems with Triad's tainted alcohol wipes.

New Recall: All lots of povidine iodine prep pads manufactured by H & P Industries Inc.

As of March 15th
H & P Industries, the parent company of the Triad Group, has issued a voluntary recall of all lots of providine idodine prep pads. The notice from H &  P stated the pads may be contaminated with "Elizabethkingia meningoseptica", an organism that has caused rare but serious infections in humans, including, pneumonia in patients on ventilators and necrotizing fasciitis, more commonly known as flesh-eating bA and meningitis in newborn infants. As noted in the press release from H & P now on the FDA's website the new recalled prep pads include povidine iodine prep pads made by H&P Industries packaged under the names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety and Total Resources.

MSNBC published this article ; FDA not ready to act on tainted wipes, despite new recall .
"Agency 'very concerned' about iodine pads tainted with dangerous bacteria, official says"
See The Press Release From H & P Here

Feb 22 2011 

USA: FDA knew of problems with Triad's tainted alcohol wipes Roche said "Triad pads are distributed with several drugs including the Boniva bone-building drug and hepatitis C treatment Pegasys."

Merck said "Triad pads were distributed with Pegintron, a treatment for hepatitis C, and a related drug, Intron A, outside the U.S. Merck said drugs distributed in the U.S. aren't affected."

Merck issued a warning about the recalled pads to customers who use Pegintron (peginterferon alfa-2b) single dose RediPen and Pegintron vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and Intron A (interferon alfa-2b) Multidose RediPen and Intron A solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Triad: http://triad-group.net/

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