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
website at
http://www.
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