September 2013 FDA Recall Risperdal Consta by Janssen Pharmaceuticals, Inc.
D-1514-2014 - Non-Sterility
This Class II drug recall was voluntarily initiated by Janssen Pharmaceuticals, Inc. on September 11, 2013 for the product Risperdal Consta. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1514-2014
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
09-11-2013
08-13-2014
70,495 kits
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 Pharmaceuticals, Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-23-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Batch or Lot Expiration Information
Lot# Vial - 4212AAP1, Kit - 309316, Exp. 07/15
