August 2012 FDA Recall Drug by Ferring Pharmaceuticals Inc
D-073-2013 - Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement

This Class III drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on August 23, 2012 for the product Drug. The FDA reported the reason for recall as labeling; incorrect or missing insert; warnings portion of the package insert is missing the warning statement. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-073-2013

Reason for Recall
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Initiated
08-23-2012
Reported
12-12-2012
Quantity
146,867 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63538
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ferring 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-30-2014
Product Description About Product Description
Full technical description of the product.
Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.

Batch or Lot Expiration Information

Lot# Lot Number Expiration Date 1C264A 09/12 1H047A 12/12 1H047B 12/12 1H052A 12/12 1H052B 04/13 1H052C 04/13 1M417A 04/13 1M417B 09/13 2A012A 09/13 2A012B 11/13 2C278A 09/13 2C278B 09/13 2C278C 11/13 2C278D 11/13 2C278E 11/13