Fougera Pharmaceuticals Inc. recalls Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Phar
Recalled March 19, 2014 · FDA recall D-1152-2014 · Fougera Pharmaceuticals
Hazard
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. · FDA Class III
Units
493,192 tubes
Sold at
Nationwide.
Description
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
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.
Manufacturer(s)
Fougera Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →