FDA Warns About Safe Use of Non-Sterile Alcohol Prep Pads Following Recall

In the wake of an alcohol prep pad recall that was issued due to microbial contamination, the FDA is reminding health care professionals to closely note whether pads are sterile or not before using them to prep injection sites. 

The FDA issued a reminder on February 1 to health care providers, indicating that quite often drug manufacturers package their products with non-sterile prep pads for preparing injection sites, and that these pads should never be used on patients who require strict sterility measures. The warning was sparked by the Triad Group alcohol swab and prep pad recall issued in early January.

The Triad Group alcohol swab recall affected prep pads, swabs and swabsticks sold under a variety of labels, including CVS and Walgreens brands. But it also has resulted in warnings from a number of drug manufacturers who packaged their injectable drugs with Triad Group prep pads for consumer convenience. To date, contaminated prep pad warnings have been issued for:

• Boniva, Fuzeon, the Nutropin A.Q. Pen, Pegasys and TNKase by Genentech
• Bayer Healthcare’s Betaseron
• Novartis’s Extavia
• GlaxoSmithKline’s Arixtra
• Relistor Injection Kits by Progenics Pharmaceuticals and Pfizer, Inc.

The pads may be contaminated with Bacillus cereus, which could pose a risk of potentially life-threatening infections. However, the FDA notes that the pads were sold as non-sterile, and should not have been used on people with weakened immune systems or on those who require strict sterility measures, such as those receiving catheter insertions or as preparation before surgery.

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.

The FDA recommends healthcare professionals always use care when utilizing pads that are not clearly marked sterile, and should treat those pads as if they are not sterile before using them or only use sterile pads.