Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Reason
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Classification
Class III
Status
Terminated
Lot
Lot #: RGAF, Exp. Date 12/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
ALMIRALL, LLC — Class III Recall | MedicineWatch US