Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Reported: October 5, 2022 Initiated: September 16, 2022 #D-1549-2022
Product Description
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
Details
- Recalling Firm
- ALMIRALL, LLC
- Units Affected
- 5,315 tubes
- Distribution
- Nationwide within the United States
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45. Recalled by ALMIRALL, LLC. Units affected: 5,315 tubes.
Why was this product recalled? ▼
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2022. Severity: Low. Recall number: D-1549-2022.
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