Malvern, PA, United States
ALMIRALL, LLC recalls
1 recall recorded since 2018, most recently on 16 September 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 16 September 2022
- Terminated
- 13 July 2023
- Reason
- Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.