Drug recall
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX…
FDA recall event 90877 · Class III · ALMIRALL, LLC
Key facts
| Event ID | 90877 |
|---|---|
| Recall numbers | D-1549-2022 |
| Recalling firm | ALMIRALL, LLC |
| Product type | Drugs |
| Products | Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Viscosity specification: Slightly higher OOS results obtained for viscosity |
| Initiation date | Sep 16, 2022 |
| Report date | Oct 5, 2022 |
| Termination date | Jul 13, 2023 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 3020689667 |
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: