Ketoconazole Cream
FDA Recall NDC 0168-0099
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Ketoconazole (NDC 0168-0099). A significant event, classified as Class II, was initiated on Apr 13, 2022 by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc. The reported reason for this action was: "cGMP deviations: Temperature abuse"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
6 tubes
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0168-0099-15Product
0168-0099-30Product
0168-0099-60Product
November 2013 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Nov 18, 2013
Feb 05, 2014
31,122 tubes
Recall Profile & Regulatory Data
Event ID
66881
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fougera Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 09, 2016
Product Description
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
0168-0099-15Product
0168-0099-30Product
0168-0099-60Product
Class III Terminated
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Jul 18, 2012
Apr 10, 2013
60,210 units
Recall Profile & Regulatory Data
Event ID
62625
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fougera Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 10, 2015
Product Description
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
Batch or Lot Expiration Information
Lot# : 835H, Exp 07/12
Affected Packages Involved in this Recall
0168-0099-15Product
0168-0099-30Product
0168-0099-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
