Triamcinolone Acetonide Cream USP — Class III drug recall D-1152-2014
Terminated recall by Fougera Pharmaceuticals Inc., reported 2014-03-19, distributed nationwide. Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1
| Recall number | D-1152-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals Inc., Melville, NY, United States |
| Recall initiated | 2014-01-29 |
| Classified | 2014-03-07 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Quantity | 493,192 tubes |
| Reason classes | labeling, potency |
| NDC | 00168-0002, 00168-0002-15, 00168-0003, 00168-0003-15, 00168-0003-80, 00168-0004, 00168-0004-15, 00168-0004-16, 00168-0004-80 |
| Lot numbers | 06/15, 07/15, 08/15, 09/15, 485P, 486P, 487P, 488P, 638P, 639P, 640P, 753P, 754P, 755P, 756P, 757P, 758P, 898P, 899P, 900P, 901P, 902P |
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 for recall
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1152-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.