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BfArM: Recall of alcohol wipes manufacturer Triad Group, Inc.

alcohol wipes, which come from the manufacturer Triad Group Inc and a variety of finished product shall form may be contaminated with Bacillus cereus.

Precise details of all drug products to which they are attached swabs are, are consulted not available. The U.S. FDA had on 6 January 2011, a recall of all Alcohol swabs manufacturer Triad Group, Inc. informed due to possible contamination with Bacillus cereus [1].
has now been shown that even in Europe swabs from this manufacturer that could be affected by the contamination, in transport: The Federal Institute for Drugs and Medical Devices (BfArM) and some pharmaceutical companies make a recall of alcohol wipes manufacturer Triad Group, Inc. carefully as they might possibly be contaminated with bacteria. It is recommended that the following items enclosed swab (Alco-Prep ©) no longer apply and dispose of:

• Enantone ®, Enantone ® Gyn, Trenantone ®, Trenantone ® Gyn, Sixantone ® (Takeda Pharma GmbH) [2]
• PegIntron ®, IntronA ® (Essex Pharma GmbH) [2]
• Application Set 30 45 30 G and G on the use of Extavia ® (Novartis Pharma GmbH) [ 3]

The drugs themselves are not affected by the recall. As yet unknown is whether the recall affected are enclosed swab further products, the BfArM has informed the associations of the pharmaceutical industry to identify appropriate products. For doctors results in no action. The AkdÄ to inform you of this fact so that doctors can answer any questions their patients.

Sources:
AKdÄ Drug Safety Mail of 4 February 2011
first FDA: Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, Alcohol and Swabsticks due to potential microbial contamination. Firm Press Release (recall) of 05 January 2011
second alcohol wipes to information from the manufacturer. Pharm Ztg 2011; 156 (5): 96-97.
third alcohol wipes to information from the manufacturer. Pharm Ztg 2011; 156 (4): 115