Food, drugs, devices › Fougera Pharmaceuticals Inc.
Drug recall: Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. F
Fougera Pharmaceuticals Inc. (Melville, NY) initiated this drug recall on 3 Jul 2014; FDA lists 2 product records under event 68683, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 7 Dec 2015. Initiation: voluntary: firm initiated. Fougera Pharmaceuticals Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fougera Pharmaceuticals Inc., Melville, NY.
Reason for recall
"Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1440-2014 | 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, 11747, NDC 0168-0337-60. | 111,388 Bottles | Class III | Terminated | 23 Jul 2014 |
| D-1441-2014 | 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, 11747, NDC 0168-0336-60. | 3,594 Bottles | Class III | Terminated | 23 Jul 2014 |
Context
Other enforcement events for Fougera Pharmaceuticals Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Mar 2017 | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., M | Drug | Class II | 1 |
| 28 Aug 2014 | FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET | Drug | Class II | 1 |
| 29 Jan 2014 | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Phar | Drug | Class III | 1 |
| 18 Nov 2013 | KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, N | Drug | Class III | 1 |
| 18 Jul 2012 | Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals I | Drug | Class III | 1 |
| 7 Jun 2012 | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Ph | Drug | Class III | 1 |
All 7 events for Fougera Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Dec 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.