Janssen Pulls 13,500 Bottles of Xarelto, Cites Contamination

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A customer complaint prompts the recall of a lot of anticoagulants from a plant in Puerto Rico.

Janssen announced in mid-October that it is recalling 13,500 bottles of Xarelto (rivaroxaban) after a customer complained about a microbial contaminant in a sales sample. Xarelto is used to reduce the risk of stroke and blood clots in people with atrial fibrillation.

The lots of the medication were traced to a facility in Gurabo, Puerto Rico, according to a recall notice in the latest FDA Enforcement Report. The recall action was voluntary, and the whole lot was recalled based on contaminants reported in only one bottle. The sales sample sizes that were pulled contained only five 15 mg pills in each bottle.  Janssen said in a statement all Xarelto dosage strengths remain available for patients and product obtained at a pharmacy is not impacted.