D-146-2013 Class III Terminated

Recalled by Ascend Therapeutics Inc — Herndon, VA

Recall Details

Product Type
Drugs
Report Date
February 13, 2013
Initiation Date
November 19, 2012
Termination Date
June 7, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4, 835 bottles

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.

Distribution Pattern

Products were distributed nationwide.

Code Information

Lot Number: EHAD Exp. 07/14