Tuesday, October 21
Janssen Pharmaceuticals has initiated a voluntary recall of 13,500 bottles of its anticoagulant drug Xarelto citing microbial contamination. In its most recent Enforcement Report, issued for the week of October 15, the U.S. Food and Drug Administration indicated that Janssen notified the agency of the problem by letter dated September 17. The company said that the recall was prompted by a consumer complaint, after which the Janssen confirmed contamination in a sales sample.
Xarelto, which is marketed by Janssen, a division of Johnson & Johnson, and jointly developed with Bayer, has been linked to fatal bleed-outs. The drug makers are now facing numerous lawsuits across the nation for deaths and serious injuries linked to use of the drug, for which there is no antidote to stop bleeding.