More Companies Recall Over Triad/Select Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

[Missouriwatcher]

January 5, 2011 - Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.

Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.

Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either ?Triad Group,? listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin

These products were distributed in the United States, Canada and Europe.

Specific customers distributing the product and selling it at the wholesale, hospital and retail pharmacy level have been 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 listing ?Triad Group? as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund or call Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900.
http://www.fda.gov/Safety/Recalls/ucm239219.htm

 

[Missouriwatcher]

Re: Recall: Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Re: Recall: Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Genentech Informs Customers Of Important Information About Triad Group's Alcohol Prep Pads

January 13, 2011 -Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, (http://www.fda.gov/Safety/Recalls/ucm239219.htm9). The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines, Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase to customers in the United States.

According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

It is important to note, that Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol for disinfecting the injection site prior to administration. Genentech is in discussion with the FDA and is currently assessing alternatives to address the situation. The company plans to issue a Dear Healthcare Provider letter to potential prescribers and pharmacists to make them aware of the Triad product recall and the need to discontinue use of the alcohol prep pads packaged with Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase.

Further information about the Triad Group recall can be found on the FDA website at
http://www.fda.gov/Safety/MedWatch/...AlertsforHumanMedicalProducts/ucm239319.htm10.

http://www.fda.gov/Safety/Recalls/ucm240131.htm

 

[Missouriwatcher]

Re: Recall: Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Re: Recall: Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Important Information for Betaseron® (interferon beta 1-b) Consumers
Regarding Triad Group’s Alcohol Prep Products

Wayne, NJ, January 8, 2011 - Bayer HealthCare Pharmaceuticals has become aware of a broad United States market recall of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. In the interest of patient safety, Bayer wants to ensure that U.S. patients and physicians using Bayer’s Betaseron are aware of the Triad recall.

The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria, Bacillus cereus, that could lead to life-threatening infections.

Triad alcohol prep pads packaged for use in the U.S. with Betaseron should not be used by patients. There is NO involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States.

Bayer instructs patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.

Bayer is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration. In the interim, Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad. Bayer has posted this important information on its websites...
http://www.fda.gov/Safety/Recalls/ucm240558.htm

 

[Missouriwatcher]

Re: Recall: Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Re: Recall: Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

PFIZER INC. AND PROGENICS ALERT PHYSICIANS AND PATIENTS TO INFORMATION RELATED TO TRIAD GROUP ALCOHOL PREP PRODUCTS INCLUDED IN U.S. RELISTOR KIT PACKAGING

January 25, 2011 - NEW YORK, N.Y. and TARRYTOWN, N.Y. ? Pfizer Inc. and Progenics Pharmaceuticals, Inc. have learned of a United States market recall of alcohol prep pads and swabs manufactured by the Triad Group. In the interest of patient safety, Pfizer and Progenics are alerting U.S. patients and physicians to Triad?s recall. Triad? Alcohol Prep Pads are packaged for use with the kit presentation of RELISTOR? (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The RELISTOR vial and other components of the kit are not affected by the defective Triad alcohol pad. RELISTOR sold in single vials also is unaffected by this recall.

Pfizer and Progenics advise patients using the RELISTOR kit not to use the Triad alcohol prep pads included in the RELISTOR packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their RELISTOR injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.

Shipments of RELISTOR kits have been suspended until the alcohol pads can be replaced, which will be done as quickly as possible to enable patients to continue to receive RELISTOR. Triad alcohol prep products are not included in RELISTOR sold as single vials or in RELISTOR kits outside of the United States or with other Pfizer medications.

The following information about the recall of Triad alcohol prep products is available on the U.S. Food and Drug Administration?s web site: Triad press release: http://www.fda.gov/Safety/Recalls/ucm239219.htm Safety information: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlerts forHumanMedicalProducts/ucm239319.htm.

Patients with questions about RELISTOR should consult their pharmacist or healthcare provider, or call Pfizer Medical Information at 1-800-438-1985. RELISTOR is manufactured and marketed by Pfizer under a licensing agreement with Progenics...
http://www.fda.gov/Safety/Recalls/ucm241070.htm

 

[Missouriwatcher]

Re: More Companies Recall Over Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Re: More Companies Recall Over Triad Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products

February 4, 2011 -Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson?s Trelstar? (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

The Company emphasized that there is no potential contamination of the Trelstar product, the MIXJECT? system or components in the Trelstar packaging, other than the Triad alcohol prep pad. The Trelstar drug and the MIXJECT? system have not been affected in any way.

Watson has ceased shipments of Trelstar packaging components that incorporate the Triad alcohol pad while it pursues options to remove or replace the prep pad. Convenience kits will not be available in Trelstar commercial packages until new convenience kits incorporating a replacement alcohol prep pad are available for distribution in March 2011. The Company also noted that it was cooperating fully with the FDA, and notifying its customers.

Watson instructs customers to immediately discontinue the use of the Triad alcohol prep pad included in the Trelstar convenience kit and to appropriately dispose of the entire convenience kit. The Company also recommends customers use an alternative alcohol prep pad product that is not involved with this recall, or to use a sterile gauze pad in conjunction with isopropyl alcohol as an alternative. Both prep pads and gauze should be available at your local pharmacy.

Further information on this Triad alcohol prep pad recall can be found on the FDA website at
http://www.fda.gov/Safety/MedWatch/...yAlertsforHumanMedicalProducts/ucm239319.htm9.

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.htm10
? Regular Mail: use postage-paid, pre-addressed Form FDA
3500 available at:www.fda.gov/MedWatch/getforms.htm11
Mail to address on the pre-addressed form.
? Fax: 1-800-FDA-0178
http://www.fda.gov/Safety/Recalls/ucm242359.htm

 

[Missouriwatcher]

Re: More Companies Recall Over Triad/Select Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

Neuro Resource Group, Inc.
Informs Customers of Important Information
about Triad Group's Alcohol Prep Pads

FOR IMMEDIATE RELEASE - February 7, 2011 -Neuro Resource Group, Inc. (NRG) has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, (http://www.fda.gov/Safety/Recalls/ucm239219.htm9). The Triad Group alcohol prep pads are co-packaged and distributed with NRG devices to customers in the United States and internationally.

According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. The Triad wipes may also be labeled ?Select?; ?Select Medical Products?; ?PSS Select?, or ?PSS World Medical, Inc.? The subject Triad/Select alcohol wipes previously provided with NRG devices should be discarded immediately. NRG is currently providing alcohol wipes that are not subject to recall.

It is important to note, that NRG devices are not contaminated and may continue to be used in accordance with the instructions for use. The alcohol wipes were provided strictly as a cleaning convenience. Patients and healthcare providers should not use the Triad/Select alcohol prep pads packaged with these devices and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a gauze or tissue pad in conjunction with 70% isopropyl alcohol for cleaning. For replacement wipes, customers may contact NRG customer service at 1-877-314-6500.

The company plans to issue a letter to customers to make them aware of the Triad product recall and the need to discontinue use of the Triad alcohol prep pads packaged with NRG products. Further information about the Triad Group recall can be found on the FDA website at: http://www.fda.gov/Safety/MedWatch/...AlertsforHumanMedicalProducts/ucm239319.htm10...
http://www.fda.gov/Safety/Recalls/ucm242736.htm

 

[Missouriwatcher]

Re: More Companies Recall Over Triad/Select Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

March 5, 2011 ? Today, Smith & Nephew?s Advanced Wound Management division (LSE: SN; NYSE: SNN) announced a U.S. voluntary nationwide recall of selected lots of IV PREP Antiseptic Wipes (product number 59421200) manufactured for Smith & Nephew by The Triad Group.

This Smith & Nephew recall follows an earlier nationwide recall initiated by The Triad Group for alcohol prep products, pads, wipes and swabs due to concerns about potential microbial contamination with Bacillus cereus. Use of contaminated alcohol prep pads, wipes and swabs could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.

Smith & Nephew has halted all shipments of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. All customers and patients are advised to discontinue use of IV PREP Antiseptic Wipes immediately, as their use could result in localized or systemic infection. All customers should dispose of or return IV PREP Antiseptic Wipes to Smith & Nephew.

Smith & Nephew is advising all distributors and kit packers who utilize IV PREP Antiseptic Wipes as a part of their kit components to discontinue use of IV PREP Antiseptic Wipes immediately, and issue a sub-recall to their customers.

The specific lot numbers involved in the recall are: 9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213. IV PREP Antiseptic Wipes represent a small part of Smith & Nephew?s overall advanced wound management business...
http://www.fda.gov/Safety/Recalls/ucm246058.htm

 

[Amish Country]

A child's death causes recall.

A child's death causes recall.

A child's death causes recall.

Parents blame toddler's death on tainted alcohol wipes
Millions of pads, swabs recalled because of same bacteria that killed 2-year-old boy.

http://www.msnbc.msn.com/id/41588330/ns/health-infectious_diseases/

 

[Missouriwatcher]

Re: More Companies Recall Over Triad/Select Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks - Microbial Contamination

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

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 Triad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Bacillus 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. Lilly 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.
http://www.fda.gov/Safety/Recalls/ucm247596.htm