Drug recall D-1549-2022

Class III Terminated reported Oct 5, 2022

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

Lots and codes

Lot #: RGAF, Exp. Date 12/2022

Recall details

Recalling firm
ALMIRALL, LLC, Malvern, PA
Quantity
5,315 tubes
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
September 16, 2022
Terminated
July 13, 2023