September 2014 FDA Recall Drug by Janssen Ortho L.l.c.
D-0006-2015 - Microbial Contamination of Non-Sterile Products
This Class II drug recall was voluntarily initiated by Janssen Ortho L.l.c. on September 17, 2014 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0006-2015
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
09-17-2014
10-15-2014
13500 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Janssen Ortho L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-11-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Batch or Lot Expiration Information
Lot# Lot 13JG2616 Exp. 07/16
