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U.S. Department of Health and Human Services

Enforcement Report - Week of October 15, 2014

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Product Detail

Product Description Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Recall Number D-0006-2015
Classification Class II
Code Info Lot 13JG2616 Exp. 07/16
Product Distributed Qty 13500 bottles
Reason For Recall Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

Event Detail

Event Id 69302
Product Type Drugs
Status Ongoing
Recalling Firm Janssen Ortho L.L.C.
City Gurabo
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-09-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide