Xarelto recall: Sterility Concern
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Why was Xarelto recalled?
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 13JG2616 Exp. 07/16
- Product
- Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
- Recalling firm
- Janssen Ortho L.L.C.
- Quantity
- 13500 bottles
- Distribution
- Nationwide
- Recall date
- October 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)