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FDAFDA · Food and drugs·Recall number 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., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.

Published March 19, 2014 · Recall initiated: January 29, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
TRIAMCINOLONE ACETONIDE
Manufacturer
Fougera Pharmaceuticals Inc.
Distributor
Nationwide.
UPC
0301680004150
Lot
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
Risk classification
Class III
Area (FDA)
drug
Country
United States

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