News Alert: Voluntary Recall of Potentially Contaminated Alcohol Prep Products Used with Injected Medications

Triad Group, a Wisconsin-based manufacturing company, is voluntarily recalling all lots of their alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured under their name (Triad Group), or under third party names (Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, and Conzellin). These lots of alcohol prep products have been recalled as a result of potential contamination with Bacillus cereus — bacteria that could lead to life-threatening infections, particularly in those whose immune system is suppressed and for individuals undergoing surgery. As of January 5, 2011, Triad Group has received one report of a non-life-threatening skin infection.

Main Points:

• Triad Group’s alcohol prep products may be contaminated with bacteria, which could potentially lead to life-threatening infections
• Alcohol prep products are used to disinfect an area of skin prior to an injection
• Betaseron uses Triad Group’s alcohol prep pads in its packaging; these pads should be discarded
• The drug Betaseron and other components of its packaging are not affected in any way
• Patients may use other brands of alcohol prep products, or a sterile gauze pad in conjunction with isopropyl alcohol, in place of Triad Group’s products
• Individuals who use any of the injectable treatments for MS, including Extavia and Copaxone, should check the manufacturer of their alcohol prep products and discontinue the use of any labeled by "Triad Group" (or those products purchased separately at retail stores under specific third-party names)

Alcohol prep products are used to disinfect an area of skin prior to an injection. Such products may be included in the packaging of injected medications, or sold separately at retail outlets to consumers. Triad Group’s products are distributed in the United States, Canada, and Europe.

This voluntary recall is being conducted with the knowledge of the United States Food and Drug Administration (FDA). The agency has posted this information on its website. Individuals may go to http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm for safety alert information, or to http://www.fda.gov/Safety/Recalls/ucm239219.htm to view the press release issued by Triad Group.

Bayer HealthCare Pharmaceuticals Inc. has also issued a press release to warn MS patients and physicians who use Betaseron® (interferon beta-1b) of this recall. While the drug in the vial as well as any other components of the packaging are unaffected, the alcohol prep pads packaged for use with Betaseron are manufactured by Triad. Anyone using Triad alcohol prep pads included in the Betaseron packaging is instructed to discontinue using these pads immediately and to throw these pads away in the trash. Triad alcohol prep products are not used in Betaseron packaging outside of the United States.

Bayer instructs patients to use an alternative, sterile alcohol prep pad that is not a part of the Triad recall. Bayer notes that a sterile gauze pad in conjunction with isopropyl alcohol may be safely used in place of a pre-packaged prep pad. Other brands of pre-packaged alcohol prep products sold at retail stores may be used; however, individuals need to make sure they are not manufactured by Triad Group or any of the third-party names given to their products (Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, and Conzellin). Anyone who has purchased one of these over-the-counter products should return it to the store where purchased.

Alcohol prep products manufactured by Triad Group may potentially be packaged with other injected MS treatments. Novartis Pharmaceuticals Corporation has sent out a media release stating that some of these alcohol prep pads from Triad may have also been included in packages of its MS drug, Extavia® (interferon beta-1b), which is the same medication as Betaseron, only marketed by a different company. As with Betaseron, the possibility of Triad alcohol prep products in the packaging does not affect the drug in the vial nor the other components of the packaging. Individuals need to check the alcohol prep pads from their packages of Extavia, and if these are manufactured by Triad, they should be disposed of and not used. Individuals may use a sterile gauze pad with isopropyl alcohol, or a different brand of alcohol prep products, in place of the Triad alcohol prep pad.

Update: Teva Neuroscience, Inc., makers of Copaxone® (glatiramer acetate), have also stated that packages of their injectable medication for MS include alcohol prep pads manufactured by Triad Group. Teva provides the following notes: the recall is limited to the prep pads only [and the medication is not affected in any way]; patients should not use any of the alcohol prep pads contained in the Copaxone pack and should discard these alcohol prep pads; patients should not in any way interrupt their daily injection routine; patients can purchase alternative alcohol prep pads at their local pharmacy or use sterile gauze pads in conjunction with bottled isopropyl alcohol in lieu of the Triad alcohol prep pads.
As more information becomes available, MSAA will update this news alert. In the meantime, MSAA recommends that anyone taking any type of injected medicine check their alcohol prep pads, alcohol swabs, and alcohol swabsticks for the manufacturer’s name. Those labeled as made by "Triad Group" should not be used.

Anyone experiencing a possible adverse reaction should contact a physician immediately. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program by calling (800) 332-1088 to obtain a form.

For More Information
MSAA’s Helpline consultants are available to answer any questions about the recall at (800) 532-7667. Additionally, patients may contact their local pharmacist who may be able to provide more specific details. Individuals may also call the numbers listed below for more information.

Triad Group Customer Service: Monday through Friday between the hours of 8:30 am and 4:00 pm Central Time
at (262) 538-2900
Bayer HealthCare Pharmaceuticals Inc.(Betaseron): BETAPLUS at (800) 788-1467, option 1 to speak with a BETA Nurse; or Bayer at (888) 84-BAYER where operators will be available 24 hours per day (website: www.multiplesclerosis.com )
Novartis Pharmaceuticals Corporation (E xtavia): Patient support and information at (866) 925-2333 or www.extavia.com
Teva Neuroscience, Inc.(Copaxone): Patient support and information at Shared Solutions, (800) 887-8100 or www.sharedsolutions.com
Other injectable MS medications and their contact information are listed below:
Avonex® (interferon beta-1a)
Patient support and information at Avonex Alliance (800) 456-2255 or www.avonex.com
Rebif® (interferon beta-1a)
Patient support and information at MS LifeLines, (877) 447-3243 or www.MSLifeLines.com

Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer