Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45

FDA recall notice · announced October 5, 2022 · Almirall

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: RGAF, Exp. Date 12/2022
Quantity: 5,315 tubes
Status: Terminated
Products in this recall event:
- Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45 (D-1549-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.