Drug product
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
D-1549-2022
Product summary
- Firm
- ALMIRALL, LLC
- Event
- Event 90877
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,315 tubes
- Official record key
drug-enforcement:D-1549-2022
Official wording
Reason: Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Code information: Lot #: RGAF, Exp. Date 12/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity