Fougera Pharmaceuticals Inc. Recalls

All product recalls associated with Fougera Pharmaceuticals Inc..

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Recall Summary

Total Recalls

8

Past Year

0

Class I (Serious)

0

Most Recent

Mar 2017

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–8 of 8 recalls

Desonide Ointment (Fougera) - Labeling Mix-up (2017)

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

Class IIModerate

FDAMar 2, 2017Nationwide• Fougera Pharmaceuticals Inc.

Fluocinonide Gel (Fougera) – Stability Specification Failure (2014)

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Class IIModerate

FDAAug 28, 2014Nationwide• Fougera Pharmaceuticals Inc.

Triamcinolone Acetonide Lotion 0.025% (Fougera) – pH Specification Issue (2014)

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Class IIILow

FDAJul 3, 2014Nationwide• Fougera Pharmaceuticals Inc.

Triamcinolone Acetonide Lotion 0.1% (Fougera) – pH Specification Issue (2014)

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Class IIILow

FDAJul 3, 2014Nationwide• Fougera Pharmaceuticals Inc.

Triamcinolone Cream (Fougera) – Labeling Error (2014)

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

Class IIILow

FDAJan 29, 2014Nationwide• Fougera Pharmaceuticals Inc.

Ketoconazole Cream (Fougera) – Degradation Specs (2013)

Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

Class IIILow

FDANov 18, 2013Nationwide• Fougera Pharmaceuticals Inc.

Ketoconazole Cream 2% (Fougera) – Specification Failure (2012)

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

Class IIILow

FDAJul 18, 2012Nationwide• Fougera Pharmaceuticals Inc.