FDAFDA · Food and drugs·Recall number D-0006-2015
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Published October 15, 2014 · Recall initiated: September 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Janssen Ortho L.L.C.
- Distributor
- Nationwide
- Lot
- Lot 13JG2616 Exp. 07/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.