Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: RGAF, Exp. Date 12/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1549-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 16, 2022
- FDA report date
- Oct 5, 2022
- Quantity
- 5,315 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALMIRALL, LLC
Original FDA data
Every field from FDA enforcement report D-1549-2022, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90877
- Address
- 101 Lindenwood Dr Ste 400
- Code information
- Lot #: RGAF, Exp. Date 12/2022
- Postal code
- 19355-1769
- Report date
- Oct 5, 2022
- Product type
- Drugs
- Recall number
- D-1549-2022
- Classification
- Class III
- Recalling firm
- ALMIRALL, LLC
- Product quantity
- 5,315 tubes
- Termination date
- Jul 13, 2023
- Reason for recall
- Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Sep 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 29, 2022