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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