Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Reported: October 15, 2014 Initiated: September 17, 2014 #D-0006-2015
Product Description
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.
Details
- Recalling Firm
- Janssen Ortho L.L.C.
- Units Affected
- 13500 bottles
- Distribution
- Nationwide
- Location
- Gurabo, PR
Frequently Asked Questions
What product was recalled? ▼
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99. Recalled by Janssen Ortho L.L.C.. Units affected: 13500 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 15, 2014. Severity: Moderate. Recall number: D-0006-2015.
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