Xarelto Recall Issued Due to Risk of Contamination

More than 13,000 bottles of the anticoagulant Xarelto are being recalled, due to a risk of microbial contamination. 

The Xarelto recall impacts one lot of the Bayer and Johnson & Johnson medication, and was announced by the FDA in an enforcement report last week. No illnesses have been linked to the recalled Xarelto tablets, and the nature of the microbial contamination has not been announced.

The recall came after at least one consumer complained about problems with a Xarelto sales sample, and subsequent investigation revealed the contamination. The recalled Xarelto was manufactured at a Johnson & Johnson plant in Gurabo.

The affected lot involves 15mg tablets of Xarelto (rivaroxaban), which were sold in 5 count bottles. The affected bottles have a lot number of 13JG2616, with NDC 50458-578-99, and an expiration date of 07/16.

The recall only affects sample versions, and not drugs distributed to patients via pharmacies. The company has sent letters to customers who received the sample bottles.

Xarelto Bleeding Concerns

The problems come amid continuing concerns about the safety of Xarelto and the risk of severe and potentially life-threatening bleeds associated with the rapidly growing medication.

Xarelto was first introduced in late 2011, as a superior alternative to Coumadin (warfarin), which has been the go-to anticoagulation therapy for years. However, it has been linked to hundreds of consumer reports involving uncontrollable bleeding problems on Xarelto, which doctors have been unable to stop due to the lack of an approved antidote that can be used to reverse the blood thinning effects of the drug.

Unlike warfarin, which can be quickly reversed if bleeding occurs, Xarelto lacks a reversal agent.

Over the past year, the manufacturers have faced a growing number of Xarelto lawsuits alleging that inadequate warnings and instructions were provided about the potential bleeding side effects of the medication and the lack of an effective reversal agent.

Many of the complaints allege that Bayer and Johnson & Johnson should have issued a Xarelto recall shortly after it was introduced, or that it never should have been approved without an effective reversal agent.

Recent studies have provided further support for the lawsuits, even undercutting the manufacturers’ claims that blood monitoring on Xarelto is not necessary.

According to the findings of a study published last month in the Journal of Cardiology, Xarelto monitoring may help identify patients at risk of severe bleeds, indicating that measuring coagulation function is clinically useful.

In response to the mounting number of product liability lawsuits over Xarelto being filed throughout the federal court system, a motion was filed earlier this month, seeking to centralize the Xarelto litigation before one judge for coordinated pretrial proceedings.

While there are currently 21 cases pending in 10 different federal district courts, many Xarelto injury lawyers reviewing potential claims have suggested that there could soon be hundreds, and possibly even thousands, of claims brought on behalf of individuals hospitalized with severe internal bleeds, brain hemorrhages, hemorrhagic strokes or other bleeding problems while taking Xarelto.