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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