FDA Drug recall D-1152-2014
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., M…
- FDA Drug
- Class III
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class III recall of Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., M… by Fougera Pharmaceuticals, citing labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1152-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-01-29 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
Product
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 0168-0004-80 8.
Reason
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Identifiers
| upc | 301680004808 |
|---|---|
| ndc | 0168-0003-15 |
| ndc | 0168-0003-80 |
| ndc | 0168-0004-15 |
| ndc | 0168-0004-80 |
| ndc | 0168-0004-16 |
| ndc | 0168-0002-15 |
| code_info | Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Fougera Pharmaceuticals
- Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 1…
FDA Drug · Class II · 2017-03-29 · Fougera Pharmaceuticals - 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,…
FDA Drug · Class II · 2014-11-19 · Fougera Pharmaceuticals - Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Divi…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals - Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Di…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals - KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC…
FDA Drug · Class III · 2014-02-05 · Fougera Pharmaceuticals
All Fougera Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1152-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.