Alcohol Prep Pads, Swabs, and Swabsticks - Recall Due to Possible Microbial Contamination - Update
February 17, 2011
Triad Group is voluntarily recalling all lots of sterile and non-sterile alcohol prep pads, swabs, and swabsticks because these products may be contaminated with Bacillus cereus. The affected products were manufactured by Triad and were also sold as private label products. The affected products may list the manufacturer as Triad Group or may list any of the following names on the product packaging: Boca/Ultilet, Cardinal Health, Conzellin, CVS, Moore Medical, PSS Select, VersaPro, Walgreens.
The affected products are sold at retail pharmacies in a box of 100 individually-wrapped packets, packaged with devices made by Neuro Resource Group, and are also packaged in some medication product kits that contain alcohol pads. Alcohol pads in the medication product kits listed below are known to be affected. Note that the medications in these product kits are not affected:
- Enfuvirtide (Fuzeon - Genentech): lyophilized powder for injection, 90 mg vials, 60-count convenience kit, NDC 00004-0390-39
- Enoxaparin (Lovenox - Sanofi-Aventis): discharge kits, used for patient education; kit does not contain any medication
- Fondaparinux (Arixtra - GlaxoSmithKline): discharge kits, used for patient education; kit does not contain any medication
- Glatiramer (Copaxone - Teva): 20 mg prefilled syringes, 30-count, NDC 68546-0317-30
- Ibandronate (Boniva - Genentech): 1 mg/mL solution in 3 mL prefilled syringe kits, NDC 00004-0188-09
- Interferon beta-1b: Betaseron (Bayer) lyophilized powder for injection, 0.3 mg vial in 14-count administration kit, NDC 50419-0523-35; and Extavia (Novartis) lyophilized powder for injection, 0.3 mg vial in 15-count administration kit, NDC 00078-0569-12
- Methylnaltrexone (Relistor - Pfizer / Wyeth): 12 mg vials, in administration kit, NDC 00008-2513-02
- Peginterferon alfa-2a (Pegasys - Genentech): prefilled syringes, in convenience pack, NDC 00004-0352-39
- Somatropin (Nutropin AQ - Genentech): 5 mg/mL solution in 2 mL pen cartridge, NDC 50242-0043-14; and 10 mg/mL solution in 2 mL pen cartridge, NDC 50242-0073-01
- Tenecteplase (TNKase - Genentech): lyophilized powder for injection, 50 mg vial, in administration kit, NDC 50242-0038-61
- Triptorelin pamoate, injectable suspension (Watson): 3.75 mg vial in Mixject kit, NDC 52544-0189-76; 11.25 mg vial in Mixject kit, NDC 52544-01882-76; and 22.5 mg vial in Mixject kit, NDC 52544-0092-76
Alcohol products are used for disinfecting the skin prior to giving injections. Use of contaminated alcohol prep pads, swabs, or swabsticks could result in serious infections, especially in immunosuppressed patients or surgery patients. Currently, only 1 non-life-threatening skin infection has been reported with the affected products
Consumers and healthcare professionals should stop using the affected alcohol products immediately.
- Boxes of individually-wrapped packets: Return the affected products for refund to the place of purchase, or by calling Triad Group Customer Service at 262-538-2900 weekdays from 8:30 AM to 4:00 PM Central Time. Report any adverse events to the FDA's Medwatch program.
- Devices made by Neuro Resource Group: Discard the alcohol prep pads in the device. Disinfect the skin with an alcohol prep pad from another manufacturer or sterile gauze with isopropyl alcohol. The devices are not contaminated and may be safely used.
- Alcohol pads in medication product kits: Discard the alcohol prep pad in the product kit. Disinfect the skin with an alcohol prep pad from another manufacturer or sterile gauze with isopropyl alcohol. The medications within the product kits are not affected and may be safely used.
Additional information is available at the following links:
- MedWatch Alert:
- FDA Press Release:
- Company Press Release:
- Triad: http://www.fda.gov/Safety/Recalls/ucm239219.htm
- Bayer: http://www.fda.gov/Safety/Recalls/ucm240558.htm
- Genentech: http://www.fda.gov/Safety/Recalls/ucm240131.htm
- GlaxoSmithKline: http://www.fda.gov/Safety/Recalls/ucm241097.htm
- Neuro Resource Group: http://www.fda.gov/Safety/Recalls/ucm242736.htm
- Novartis: http://www.fda.gov/Safety/Recalls/ucm241610.htm
- Pfizer / Progenics: http://www.fda.gov/Safety/Recalls/ucm241070.htm
- Watson: http://www.fda.gov/Safety/Recalls/ucm242359.htm
- ASHP Drug Shortage Page:
February 17, 2011; January 7, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.