ALMIRALL, LLC recalls Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16…
- Recall date
- September 16, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1549-2022
- FDA classification
- Class III
- Brand / firm
- ALMIRALL, LLC
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
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