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

FDA recall notice · announced October 15, 2014 · Janssen Ortho

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot 13JG2616 Exp. 07/16
Quantity: 13500 bottles
Status: Terminated
Products in this recall event:
- Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 (D-0006-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.