Reported Oct 15, 2014 · Terminated

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC…

Janssen Ortho LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Janssen Ortho L.L.C. · Carr # 933 Km 0.1 · Gurabo, PR · 00778

Is this the product you have?

  • Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only
  • Manufactured byJOLLC, Gurabo, PR 00778 NDC 50458-578-99
Lot codes and dates
  • Lot 13JG2616 Exp. 07/16
Amount recalled
13500 bottles

Where it was sold

  • Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 11, 2016 · Data as of Sep 19, 8:05 PM UTC

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