Why it was recalled
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Product description
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Lot numbers, UPCs & expiration codes
Lot 13JG2616 Exp. 07/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0006-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 13500 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Janssen Ortho L.L.C.
Original FDA data
Every field from FDA enforcement report D-0006-2015, exactly as published.
Show all FDA fields
- City
- Gurabo
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 69302
- Address
- Carr # 933 Km 0.1
- Address (line 2)
- Mamey Ward
- Code information
- Lot 13JG2616 Exp. 07/16
- Postal code
- 00778
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0006-2015
- Classification
- Class II
- Recalling firm
- Janssen Ortho L.L.C.
- Product quantity
- 13500 bottles
- Termination date
- Oct 11, 2016
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 17, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2014