Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Recall Number: D-1549-2022
Firm: ALMIRALL, LLC
Classification: Class III
Status: Terminated
Report Date: 20221005
Initiation Date: 20220916
Termination Date: 20230713
Reason for Recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Product Description
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45