GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.
Some of these alcohol prep pads from Triad may have been included in U.S. packaging for ARIXTRA® Starter Kits manufactured by GSK. The Triad alcohol prep pads should NOT be used.
It is important to note that this recall does not affect or involve actual ARIXTRA (fondaparinux sodium). The Starter Kits do not contain ARIXTRA; they only contain dosing instructions, an education booklet, a needle box, and alcohol prep pads to wipe the injection site. Further, the alcohol prep pads involved in this recall were not manufactured by GSK.
Patient safety is a top priority and GSK wants to ensure that U.S. patients and physicians using ARIXTRA Starter Kits are aware of the Triad recall and what they should do.
Patients using ARIXTRA Starter Kits titled "Looking Ahead with ARIXTRA" should immediately discontinue using the Triad alcohol prep pads included in the ARIXTRA Starter Kit and should dispose of those pads in the trash. When preparing to take their ARIXTRA injection, patients should prepare the injection site in either of the following ways: By rubbing the area with (i) sterile gauze and 70% isopropyl alcohol, or (ii) alcohol prep pads – from another manufacturer – which are not the subject of a recall. These items are generally available at most retail pharmacies.
GSK is working with the U.S. Food and Drug Administration (FDA) on this recall. GSK has halted all shipments of ARIXTRA Starter Kits containing the Triad alcohol prep products to its distribution network.
Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/Recalls/ucm239219.htm If you have additional questions regarding ARIXTRA Starter Kits, please consult with your pharmacist or healthcare provider or contact the GSK Response Center at 1-888-825-5249.
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