Reported Mar 19, 2014 · Terminated

Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera…

Fougera Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fougera Pharmaceuticals Inc. · 60 Baylis Rd · Melville, NY · 11747-3838

Is this the product you have?

  • 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.
Lot codes and dates
    • 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
Amount recalled
493,192 tubes

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 8, 2015 · Data as of Sep 19, 7:53 PM UTC

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