September 2022 FDA Recall Drug by Almirall, Llc
D-1549-2022 - Failed Viscosity specification

This Class III drug recall was voluntarily initiated by Almirall, Llc on September 16, 2022 for the product Drug. The FDA reported the reason for recall as failed viscosity specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1549-2022

Reason for Recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Initiated
09-16-2022
Reported
10-05-2022
Quantity
5,315 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90877
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ALMIRALL, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-13-2023
Product Description About Product Description
Full technical description of the product.
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45

Batch or Lot Expiration Information

Lot# : RGAF, Exp. Date 12/2022