FDA-Drug2014-03-19Class III

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.

Fougera Pharmaceuticals Inc.
Hazard

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

Sold states
Nationwide.
Affected count
493,192 tubes
Manufactured in
60 Baylis Rd, N/A, Melville, NY, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1152-2014

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