EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use...
FDA Recall #D-146-2013 — Class III — November 19, 2012
Product Description
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***
Reason for Recall
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Recalling Firm
Ascend Therapeutics Inc — Herndon, VA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4, 835 bottles
Distribution
Products were distributed nationwide.
Code Information
Lot Number: EHAD Exp. 07/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated