Reported Sep 21, 2022 · Completed

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534,…

Direct Rx

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828

Is this the product you have?

  • Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only
  • Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80
Lot codes and dates
  • Lot
    • 12JY2216
    • Exp. 2/29/24
Amount recalled
20 tubes

Where it was sold

Why it was recalled

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:55 PM UTC

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