Xolegel recall
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Why was Xolegel recalled?
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: RGAF, Exp. Date 12/2022
- Product
- Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- Recalling firm
- ALMIRALL, LLC
- Quantity
- 5,315 tubes
- Distribution
- Nationwide within the United States
- Recall date
- October 5, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)