ALMIRALL, LLC: Drug Recall
Recall #D-1549-2022 · 09/16/2022
Class III: Low Risk
Recall Details
- Recall Number
- D-1549-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- ALMIRALL, LLC
- Status
- Terminated
- Date Initiated
- 09/16/2022
- Location
- Malvern, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,315 tubes
Reason for Recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Product Description
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Distribution Pattern
Nationwide within the United States
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.