Monday, February 14, 2011

Contaminated Alcohol Prep Pads and Infections

The FDA has announced a recall of ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group due potential contamination of the products with Bacillus cereus, a bacteria that produces toxins that cause diarrhea, nausea and vomiting often related to food poisoning. FDA Recall Announcement.  This bacteria can cause serious injuries and death if it is introduced into the blood stream or cerebrospinal fluid (CSF). The recall covers Triad Group brand alcohol swabs and others which are private labeled for many accounts to the consumer level. This recall also involves those products marked as STERILE as well as non-sterile products. This recall also includes the drugs and medical equipement in which it is co-packaged. 
Regular users of injectable medications, such as Copaxone or Betaseron for Multiple Sclerosis (MS), are at very high risk because they use the alcohol wipes daily and are asked to break the skin with an injection after exposing it to the bacterial contamination on Triad products.
The Food and Drug Administration says that use of contaminated Triad Alcohol Group Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. Triad Group Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected alcohol prep pads, alcohol swabs and alcohol swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin
But, the problem is bigger than just the prep pads and swabs for individual use. Triad Group also provides prep pads and swabs for inclusion in prepackaged drug and surgical instrument packets. Progenics Pharmaceuticals, Inc. and Pfizer Inc. have issued a Relistor warning because the drug was packaged with the contaminated Triad Group alcohol prep pads. The manufacturers indicate that there are no problems with the actual drug, but the packaged alcohol prep pads with Relistor should not be used. Some of these alcohol prep pads from Triad may have been included in U.S. packaging for ARIXTRA® Starter Kits manufactured by Glaxosmithkline.
The recalled Triad Group alcohol prep pad are also co-pckaged and distributed with the followiing Genentech, Inc. medicines in the United States: Boniva Injections, Fuzeon, Nutropn A.Q. Pen, Pegasys, and TNKase.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm

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