FDA recall D-146-2013

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***

Reason for recall

Defective Container: Pump head detaching from the canister unit upon removal of the overcap.

Distribution

Products were distributed nationwide.

Key facts

Status

Terminated

Initiation date

2012-11-19

Report date

2013-02-13

Termination date

2013-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Herndon, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-146-2013