D-1549-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 5, 2022
- Initiation Date
- September 16, 2022
- Termination Date
- July 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,315 tubes
Product Description
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Reason for Recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: RGAF, Exp. Date 12/2022