Key Takeaway

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 Hernd by Ascend Therapeutics Inc was recalled on November 19, 2012. The hazard: Defective Container: Pump head detaching from the canister unit upon removal of the overcap.

FDA Drug Class III Terminated

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 Hernd

Recalled: November 19, 2012 ~4, 835 bottles units affected D-146-2013

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***

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 Hernd

Drugs

Company Information

Ascend Therapeutics Inc

Herndon, VA, United States

View all 1 recalls by Ascend Therapeutics Inc →

Distribution

Products were distributed nationwide.

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Frequently Asked Questions

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