October 22, 2014 — Janssen Pharmaceuticals is recalling 13,500 bottles of Xarelto (rivaroxaban) after receiving a customer complaint confirming microbial contamination in a sales sample.
The FDA has designated it a Class II recall, meaning they believe the problem would only cause temporary or medically reversible side effects and the probability of serious consequences is low.
No illnesses have been linked to the recall. The FDA did not elaborate on the nature of the microbial contamination.
The recall involves 15-mg tablets of Xarelto that were sold in 5-count bottles. They were only provided as sales samples, not full prescriptions distributed to patients through pharmacies. The affected bottles are marked with lot number of 13JG2616, NDC 50458-578-99, and an expiration date of 07/16.
Xarelto is a powerful blood-thinning medication that has gained popularity in recent years as an alternative to Coumadin (warfarin), the mainstay of anticoagulation therapy since the 1950s.
Recently, at least a 21 lawsuits have been filed in U.S. courts by people who accuse Janssen and Bayer of downplaying the risk of deadly bleeding from Xarelto. Unlike warfarin, which can be de-activated with a dose of Vitamin K, doctors may be unable to stop bleeding in a Xarelto patient because it has no reversal agent.
Studies comparing the two drugs have linked Xarelto to higher rates of gastrointestinal bleeding and more blood transfusions. The risk of bleeding peaks in patients who have high levels of Xarelto in their blood. Some studies suggest that regular monitoring the blood of patients treated with Xarelto might help identify patients who are most at risk of internal bleeding.
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