Recalls / Class II
Class IID-0006-2015
Product
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
- Affected lot / code info
- Lot 13JG2616 Exp. 07/16
Why it was recalled
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Recalling firm
- Firm
- Janssen Ortho L.L.C.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Carr # 933 Km 0.1, Mamey Ward, Gurabo, Puerto Rico 00778
Distribution
- Quantity
- 13500 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-17
- FDA classified
- 2014-10-03
- Posted by FDA
- 2014-10-15
- Terminated
- 2016-10-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0006-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.