Health > Recalls

Recall of Contaminated Alcohol Wipes

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JimB:

It took fast-acting doctors at a Colorado hospital to flag problems with tainted alcohol wipes now tied to a massive recall and growing reports of potentially deadly infections, including the case of a 10-year-old boy already battling leukemia.  Source

And Feds knew before hand....

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.

Source

Mimi:
They have contracted Gaddaffi-itis. They will let us die one way or another without a word of warning. Unbelievable! I am not so sure God is still blessing America.  :(

Dora:
Hard to see how He can bless this country, dear Sybil!

Mimi:
More recalls:

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 
Lilly Announces Important Action Regarding Recall
of Alcohol Prep Pads Made by Triad Group Included in Forteo Starter Kits
This Recall Does Not Affect or Involve Forteo Delivery Device

 

Contact:
Tamara Hull
(317) 651-9116
 

FOR IMMEDIATE RELEASE - March 17, 2011 - INDIANAPOLIS, March 17, 2011 – Eli Lilly and Company (NYSE: LLY) announced today that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo® [teriparatide (rDNA origin) injection] in the United States. The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device.

Some Forteo starter kits distributed by Eli Lilly and Company between March 2008 and June 2009 may have contained Triad Group alcohol prep pads. The Triad alcohol prep pads should not be used. The Forteo starter kits that contained the Triad alcohol prep pads were black bags and were discontinued in June 2009. The Forteo starter kits have been updated since June 2009. The bags are now blue, do not include Triad alcohol prep pads, nor any other alcohol prep pad.

Lilly has requested that physicians and their staff examine their inventory of Forteo starter kits and remove and appropriately discard the Triad Group alcohol prep pads in the black bags. Lil-ly has also requested that physicians inform any patients who may have received Forteo starter kits containing Triad Group alcohol prep pads to discontinue use of the pads.

Further information about this recall can be found at http://www.fda.gov/Safety/Recalls/ucm239219.htm1. For questions pertaining to the recall, consumers may contact Triad Group at 262-538-2900.

Adverse reactions or quality problems experienced with the use of the Triad alcohol prep pads may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    * Online: www.fda.gov/medwatch/report.htm2
    * Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm3
    * Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    * Fax: 1-800-FDA-0178

Mimi:
Recalling some iodine wipes, as well:

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

 

Contact:
Customer Service
262-538-2900

 

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
VHA
Triad
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.
 

    * Online:www.fda.gov/medwatch/report.htm1
    * Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. 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.

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