D-146-2013 Class III Terminated
FDA drug recall D-146-2013 was initiated by Ascend Therapeutics Inc on November 19, 2012 and is designated Class III. Reason for recall: Defective Container: Pump head detaching from the canister unit upon removal of the overcap. The recall status is terminated (terminated June 7, 2013). Affected quantity: 4, 835 bottles.
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