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January 19, 2011

Manufacturer Recalls Alcohol Swab Products Packaged with Fuzeon, Other Meds

Triad Group, a manufacturer of alcohol prep pads, alcohol swabs and alcohol swab sticks, announced it is recalling all of these products because of concerns that they may be contaminated with a bacterium known as Bacillus cereus. The Triad Group alcohol prep pads are co-packaged and distributed with some medications used by people living with HIV, including Genentech's Fuzeon (enfuvirtide) and Pegasys (pegylated interferon, used to treat chronic hepatitis C virus infection).

This bacterium, typically found in the soil, can cause diarrhea and vomiting when it infects humans and can be life threatening in people with compromised immune systems. Triad Group says it has received one report of a non-life-threatening infection from this bacterium associated with its alcohol swab products.

In a statement of its own, Genentech noted that its medicines are not contaminated and may continue to be used in accordance with the package insert. However, the company warns that patients and health care providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol for disinfecting the injection site prior to administration. 

Genentech is in discussion with the U.S. Food and Drug Administration and is currently assessing alternatives to address the situation.

People who have used any Triad Group products and developed an infection from Bacillus cereus are also encouraged to contact the U.S. Food and Drug Administration (FDA) to report the incident; that web site is http://www.fda.gov/MedWatch/report.htm, and the fax number is 1-800-FDA-0178.

Search: Alcohol swab, alcohol swab stick, alcohol prep pad, Triad Group, FDA, recall, Walgreens, CVS

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