Home / Recalls / Janssen Ortho L.L.C. / D-0006-2015

D-0006-2015 Class II Terminated

Recalled by Janssen Ortho L.L.C. — Gurabo, PR

Recall Details

Product Type: Drugs
Report Date: October 15, 2014
Initiation Date: September 17, 2014
Termination Date: October 11, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13500 bottles

Product Description

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot 13JG2616 Exp. 07/16