FDA-Drug2022-10-05Class III
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
ALMIRALL, LLC
Hazard
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Sold states
Nationwide within the United States
Affected count
5,315 tubes
Manufactured in
101 Lindenwood Dr Ste 400, N/A, Malvern, PA, United States
Products
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1549-2022Don't want to check this manually?
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