FDA recall D-1549-2022

ALMIRALL, LLC · Class III · drug

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

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2022-09-16
Report date: 2022-10-05
Termination date: 2023-07-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1549-2022