Janssen Ortho L.L.C. recalls Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50
Recalled October 15, 2014 · FDA recall D-0006-2015 · Janssen Ortho L.L.C
Hazard
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample. · FDA Class II
Units
13500 bottles
Sold at
Nationwide
Description
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Product
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Manufacturer(s)
Janssen Ortho L.L.C.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →