Alcohol Swab Recall Affects Several Genentech Medications
A warning has been issued to users of a number of Genentech drugs, such as Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys and TNKase, that the medications were packaged with recalled Triad alcohol prep pads that were pulled from the market due to the potential for microbial contamination.
On January 13, Genentech issued a press release confirming that Triad Group alcohol prep pads were included in packages with Boniva injections, Fuzeon, the Nutropin A.Q. Pen, Pegasys and TNKase that were shipped to customers across the United States. The alcohol prep pads could be contaminated with the bacteria Bacillus cereus.
Earlier this month the FDA announced a Triad Group alcohol prep pad recall that affected pads, alcohol swabs and swabsticks, due to the risk of potential contamination. The prep pads, swabs and swabsticks were sold together with several medications and individually under a variety of labels, including CVS and Walgreens brands.
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The Genentech press release emphasizes that the Genentech medicines packaged with the alcohol prep pads are not known to be contaminated and can continue to be used. However, the company warns consumers not to use the alcohol prep pads packaged with them and recommends that they use an alternate prep pad that was not affected by the Triad Group recall. They can also use a sterile gauze pad along with isopropyl alcohol to prepare the injection site.
Genetech said it is in discussion with the FDA on other ways to address the situation and plans to issue a Dear Healthcare Provider letter to healthcare professionals to alert them to the need to get rid of the prep pads packaged with the medications.
Bacillus cereus is responsible for about two percent of all foodborne illness, according to the U.S. Centers for Disease Control and Prevention (CDC). Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare.
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