Important Information for BetaseronÃ‚® (interferon beta 1-b) Consumers Regarding Triad Group's Alcohol Prep Products
WAYNE, N.J., Jan. 8, 2011 /PRNewswire/ --- 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.
Further information on this Triad recall can be found on the FDA