April 2015 FDA Recall Drug by Janssen Pharmaceuticals, Inc.
D-1063-2015 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Janssen Pharmaceuticals, Inc. on April 29, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1063-2015

Reason for Recall
Subpotent Drug
Initiated
04-29-2015
Reported
05-20-2015
Quantity
16,861 cartons/6 blister units (28 tablets) each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71064
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-13-2018
Product Description About Product Description
Full technical description of the product.
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

Batch or Lot Expiration Information

Lot# 13CM724, Exp.09/15 (US)
Lot# (L) 13DM732, Exp. 09/15 (Canada)