FDA Drug recall 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 Divi…
- FDA Drug
- Class III
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class III recall of Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Divi… by Fougera Pharmaceuticals, citing failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1440-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-03 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Identifiers
| code_info | Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1440-2014%22
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