Drug recall
EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician…
FDA recall event 64116 · Class III · Ascend Therapeutics Inc
Key facts
| Event ID | 64116 |
|---|---|
| Recall numbers | D-146-2013 |
| Recalling firm | Ascend Therapeutics Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Container: Pump head detaching from the canister unit upon removal of the overcap. |
| Initiation date | Nov 19, 2012 |
| Report date | Feb 13, 2013 |
| Termination date | Jun 7, 2013 |
| City | Herndon |
| State | VA |
| Country | United States |
| FEI number | 3004088932 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: