January 10, 2011
Triad Group recalls alcohol prep products, Betaseron users affectedTriad Group and the FDA have notified healthcare professionals and patients of a voluntary, nationwide recall of all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks. The affected products are manufactured by Triad but sold under private labels at the consumer level: Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, Conzellin. This recall is due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile products.
Aware of this recall, Bayer Healthcare has announced that patients receiving Betaseron (interferon beta-1b injection) therapy should not use the Triad alcohol prep pads that are packaged for use with Betaseron. There is no involvement or potential contamination of the Betaseron vial or other components in the Betaseron packaging. Patients are advised to use an alternative alcohol prep pad not subject to the Triad recall. Betaseron is indicated to reduce the frequency of clinical exacerbations in patients with relapsing forms of multiple sclerosis (MS), and in those who have experienced a first clinical episode and have MRI features consistent with MS.
Healthcare professionals and patients who have the recalled products in their possession should stop using them immediately. Use of these contaminated products could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
For more information call Triad at (262) 538-2900, Bayer Healtcare at (888) 84-BAYER or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.