Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 161
Summary
The FDA issued a Class III for Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Labo by ALMIRALL, LLC. Reason: Failed Viscosity specification: Slightly higher OOS results obtained for viscosity.
Details
Source
Drug Recall
External ID
D-1549-2022
Action Date
2022-10-05
Status
Terminated
Category
drug
Product Description
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Lot/Code Info: Lot #: RGAF, Exp. Date 12/2022
Quantity Affected: 5,315 tubes
Reason for Recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-16
Company
Malvern, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ALMIRALL, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ALMIRALL, LLC have FDA actions?
This is the only FDA action we have on record for ALMIRALL, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1549-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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