Reported Oct 5, 2022 · Terminated
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC…
Almirall, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ALMIRALL, LLC · 101 Lindenwood Dr Ste 400 · Malvern, PA · 19355-1769
Is this the product you have?
Xolegel (ketoconazole) gel 2%45 gram tubesRx only
- Manufactured byDPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- Lot codes and dates
- Lot #: RGAF, Exp. Date 12/2022
- Amount recalled
- 5,315 tubes
Where it was sold
- Nationwide
Why it was recalled
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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