Home / Recalls / Fougera Pharmaceuticals Inc. / D-241-2013

D-241-2013 Class III Terminated

Recalled by Fougera Pharmaceuticals Inc. — Melville, NY

Recall Details

Product Type
Drugs
Report Date
April 10, 2013
Initiation Date
July 18, 2012
Termination Date
December 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,210 units

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

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

Distribution Pattern

Nationwide

Code Information

Lot #: 835H, Exp 07/12

Other recalls by Fougera Pharmaceuticals Inc.

  • D-0612-2017 Class II — Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A di (March 2, 2017)
  • D-0245-2015 Class II — FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic (August 28, 2014)
  • D-1440-2014 Class III — Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologi (July 3, 2014)
  • D-1441-2014 Class III — Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatolo (July 3, 2014)
  • D-1152-2014 Class III — Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. F (January 29, 2014)
  • D-1044-2014 Class III — KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of F (November 18, 2013)
  • D-1426-2012 Class III — Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. (June 7, 2012)