FDA-Drug2014-10-15Class II
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Janssen Ortho L.L.C.
Hazard
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Sold states
Nationwide
Affected count
13500 bottles
Manufactured in
Carr # 933 Km 0.1, Mamey Ward, Gurabo, PR, United States
Products
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief