FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Fougera Ketoconazole Cream 2% Recall

Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E

Fougera Pharmaceuticals Inc. · Melville, NY

Risk level
Class III
Reported by FDA
Apr 10, 2013
Recall ID
D-241-2013
Check your lot numberHow we source this data

Summary

Fougera Pharmaceuticals recalled Fougera Ketoconazole Cream 2% starting Jul 18, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-241-2013 on Apr 10, 2013. Reason: 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. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot #: 835H, Exp 07/12

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-241-2013
Classification
Class III
Status
Terminated
Recall initiated
Jul 18, 2012
FDA report date
Apr 10, 2013
Quantity
60,210 units
Recall type
Voluntary: Firm initiated
Recalling firm
Fougera Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-241-2013, exactly as published.

Show all FDA fields
City
Melville
State
NY
Status
Terminated
Country
United States
Event ID
62625
Address
60 Baylis Road
Code information
Lot #: 835H, Exp 07/12
Postal code
11747-0103
Report date
Apr 10, 2013
Product type
Drugs
Recall number
D-241-2013
Classification
Class III
Recalling firm
Fougera Pharmaceuticals Inc.
Product quantity
60,210 units
Termination date
Dec 10, 2015
Reason for recall
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
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Jul 18, 2012
Initial firm notification
Letter
Center classification date
Apr 2, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-241-2013, published Apr 10, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls