Status
Terminated
Drug Enforcement D-1549-2022
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
1 Views
Classification
Class III
Report Date
October 5, 2022
Termination Date
July 13, 2023
Product Information
- Product description
- Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- Product quantity
- 5,315 tubes
- Reason for recall
- Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- ALMIRALL, LLC
- Address
-
101 Lindenwood Dr Ste 400, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1549-2022
- Event ID
- 90877
- Recall initiation date
- September 16, 2022
- Center classification date
- September 29, 2022
- Code info
- Lot #: RGAF, Exp. Date 12/2022
- More code info
- —