FDAFDA · Food and drugs·Recall number D-1549-2022
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Published October 5, 2022 · Recall initiated: September 16, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ALMIRALL, LLC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: RGAF, Exp. Date 12/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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