Fougera Pharmaceuticals, Inc.
Hicksville, NY, United States
8
Total Recalls
0
Class I Recalls
0
Ongoing Recalls
Recalls by Fougera Pharmaceuticals, Inc.
FDA Drug
Class II
Terminated
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
March 2, 2017
Fougera Pharmaceuticals, Inc.
14,665 tubes units
FDA Drug
Class II
Terminated
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.,
August 28, 2014
Fougera Pharmaceuticals, Inc.
a) 59,622 Tubes; b) 43,178 Tubes units
FDA Drug
Class III
Terminated
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 117
July 3, 2014
Fougera Pharmaceuticals, Inc.
111,388 Bottles units
FDA Drug
Class III
Terminated
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 1
July 3, 2014
Fougera Pharmaceuticals, Inc.
3,594 Bottles units
FDA Drug
Class III
Terminated
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-8
January 29, 2014
Fougera Pharmaceuticals, Inc.
493,192 tubes units
FDA Drug
Class III
Terminated
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.
November 18, 2013
Fougera Pharmaceuticals, Inc.
31,122 tubes units
FDA Drug
Class III
Terminated
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
July 18, 2012
Fougera Pharmaceuticals, Inc.
60,210 units units
FDA Drug
Class III
Terminated
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215
June 7, 2012
Fougera Pharmaceuticals, Inc.
444 bottles units