November 2013 FDA Recall Ketoconazole by Fougera Pharmaceuticals Inc.
D-1044-2014 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Fougera Pharmaceuticals Inc. on November 18, 2013 for the product Ketoconazole. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1044-2014

Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Initiated
11-18-2013
Reported
02-05-2014
Quantity
31,122 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66881
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.
Fougera Pharmaceuticals Inc.
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2016
Product Description About Product Description
Full technical description of the product.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.

Batch or Lot Expiration Information

Lot# : 495P, Exp 07/14

Affected Packages Involved in this Recall

0168-0099-15 Ketoconazole
0168-0099-30 Ketoconazole
0168-0099-60 Ketoconazole