October 22, 2014 — The FDA has issued a Class II recall for about 13,500 bottles of Xarelto (rivaroxaban), a blood-thinning medication made by Janssen Pharmaceuticals and Bayer HealthCare.
The Class II recall was issued after one customer complained about microbial contamination. No illnesses were linked to the recall and details were not provided about the nature of the contamination.
The recall only affects sales samples that contained 15-mg tablets in 5-count bottles. It does not affect prescription products that may have been dispensed to a patient from a pharmacy. The bottles are marked with lot number of 13JG2616, NDC 50458-578-99, and an expiration date of 07/16.
Class II recalls are issued when the FDA believes the probability of serious health problems is low. If side effects do occur, they would likely be temporary or medically reversible.
Janssen and Bayer are now facing at least 21 lawsuits from people who were injured or died from severe bleeding. Members of the litigation accuse drug-makers of downplaying the risk of uncontrollable bleeding.
Recent studies have linked Xarelto with a higher risk of gastrointestinal bleeding and blood transfusions than Coumadin (warfarin). Unlike warfarin, which can be de-activated with a dose of Vitamin K, Xarelto has no reversal agent. Some studies suggest that routine blood tests to detect high concentrations of Xarelto in the bloodstream, which might help identify patients at greatest risk.
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