Class III
Terminated
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- Company
- Almirall, Llc
- Recall Initiated
- September 16, 2022
- Posted
- October 5, 2022
- Recall Number
- D-1549-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,315 tubes
- Firm Location
- Malvern, PA, United States
Reason for Recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: RGAF, Exp. Date 12/2022
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