September 2013 FDA Recall Endometrin by Ferring Pharmaceuticals Inc
D-1426-2014 - Discoloration; due to prolonged heat exposure.

This Class III drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on September 19, 2013 for the product Endometrin. The FDA reported the reason for recall as discoloration; due to prolonged heat exposure.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1426-2014

Reason for Recall
Discoloration; due to prolonged heat exposure.
Initiated
09-19-2013
Reported
07-16-2014
Quantity
72,046 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66604
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.
02-19-2015
Product Description About Product Description
Full technical description of the product.
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

Batch or Lot Expiration Information

Lot# Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15

Affected Packages Involved in this Recall

55566-6500-1 Endometrin
55566-6500-2 Endometrin
55566-6500-3 Endometrin
55566-6500-4 Endometrin
55566-6500-7 Endometrin
55566-6500-8 Endometrin