Saturday, March 19, 2011

Mar 15th "New Recall" On Triads Tainted Wipes:'Significant pathogens' may be found in povidine iodine prep pads

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 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 on the FDA website (see below) 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 yesterday on the wipes; FDA not ready to act on tainted wipes, despite new recall . "Agency 'very concerned' about iodine pads tainted with dangerous bacteria, official says"

The FDA has the "H&P" voluntary recall on their website;

H&P Industries, Inc. Issues a Voluntary Nationwide Recall of All Lots of
Povidine Iodine Prep Pads Due to Potential Microbial Contamination

Contact:Customer Service262-538-2900
FOR IMMEDIATE RELEASE — March 15, 2011 —Hartland, Wisconsin, H&P industries, Inc., a manufacturer of over-the-counter products has initiated a voluntary product recall of ALL LOTS of POVIDINE PREP PADS manufactured by H&P Industries, Inc. but which are private labeled for many accounts. This recall has been initiated due to results of the FDA’s ongoing investigation and sampling efforts, and H&P Industries, Inc. internal investigation.

The Povidine Iodine Prep Pads are non-sterile and contain some of the same raw material as the recalled Alcohol Prep pads, and were therefore investigated by FDA and by H&P Industries for potential contamination with objectionable organisms. However, analytical testing showed the presence of objectionable organisms, namely Elizabethkingia meningoseptica.

We are therefore taking immediate action to voluntarily recall the Povidine Iodine Prep Pads. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections. To date we have not received any reports of adverse events.

Povidine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets. The affected Povidine Iodine Prep Pads can be identified by the names listed below in their packaging:

Cardinal Health
Medical Specialties
Triad Plus
North Safety
Total Resources

These products were distributed in the United States. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession, they should not use the product and should return it to the place it was purchased for a full refund or call H&P Industries, Inc. Customer Service Monday through Friday between the hours of 8:30 a.m. and 4:00 p.m. Central Time: 262.538.2900.

DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call H&P Industries, Inc. Customer Service listed below and we will issue you a return authorization number and make all return arrangements.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

Read More At MSNBC;
Special report: Tracking tainted wipes
Latest; FDA not ready to act on tainted wipes, despite new recall .
Mar 18; Deadly infection risk triggers new recall from embattled medical supply maker
Parents blame toddler's death on tainted wipes
FDA knew of problems at plant that made tainted wipes
FDA defends actions on tainted wipes
Colo. hospital blew whistle on tainted wipes
Related On This Blog;
Mar 12th Triad Group; Supplier shutting down the line that made tainted wipes
Feb 12 Hepatitis C Medicines; Packaged With Triad Group Alcohol Prep Pads
Questions Raised About FDA Handling of Triad Problems
By John Gever, Senior Editor, MedPage TodayPublished:
February 23, 2011
Although FDA inspectors had reported a host of quality-control problems at Triad Group long before it recalled millions of contaminated alcohol-based prep pads, swabs, and jellies, the agency mysteriously took no corrective action, according an report.Citing FDA inspection reports provided by an anonymous source, the website alleged that the agency knew about "shoddy sterilization practices" at Triad Group's plant in 2009, yet did not issue a warning letter or alert customers or physicians.
Related;Warning issued to Fuzeon, Pegasys, Viraferon Peg and Intron A users
The US Food and Drug Administration has issued a warning to users of four injectable drugs that may be used by people with HIV and/or hepatitis C regarding microbial contamination of alcohol
Hepatitis C News;Recalled Alcohol Prep Pads possibly linked to the death of a child

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