Drug product
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
Product summary
- Event
- Event 69302
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13500 bottles
- Official record key
drug-enforcement:D-0006-2015
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Code information: Lot 13JG2616 Exp. 07/16
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination