November 2012 FDA Recall Drug by Ascend Therapeutics Inc
D-146-2013 - Defective Container

This Class III drug recall was voluntarily initiated by Ascend Therapeutics Inc on November 19, 2012 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-146-2013

Reason for Recall
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Initiated
11-19-2012
Reported
02-13-2013
Quantity
4, 835 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64116
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.
Ascend Therapeutics 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.
Products were distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2013
Product Description About Product Description
Full technical description of the product.
EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***

Batch or Lot Expiration Information

Lot# Lot Number: EHAD Exp. 07/14