FDA recall D-0006-2015

Janssen Ortho L.L.C. · Class II · drug

Product

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

Nationwide

Key facts

Status
Terminated
Initiation date
2014-09-17
Report date
2014-10-15
Termination date
2016-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gurabo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2015