Home / Recalls / Fougera Pharmaceuticals Inc. / D-0612-2017

D-0612-2017 Class II Terminated

Recalled by Fougera Pharmaceuticals Inc. — Melville, NY

Recall Details

Product Type: Drugs
Report Date: March 29, 2017
Initiation Date: March 2, 2017
Termination Date: July 2, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,665 tubes

Product Description

Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)

Other recalls by Fougera Pharmaceuticals Inc.

D-0245-2015 Class II — FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic (August 28, 2014)
D-1441-2014 Class III — Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatolo (July 3, 2014)
D-1440-2014 Class III — Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologi (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-241-2013 Class III — Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., (July 18, 2012)
D-1426-2012 Class III — Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. (June 7, 2012)