ALMIRALL, LLC recalls Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 161
Recalled October 5, 2022 · FDA recall D-1549-2022 · ALMIRALL
Hazard
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity · FDA Class III
Units
5,315 tubes
Sold at
Nationwide within the United States
Description
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Product
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Manufacturer(s)
ALMIRALL, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →