Reported Nov 30, 2016 · Terminated

Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by…

Akorn Inc.

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: Akorn Inc · 1925 W Field Ct · Lake Forest, IL · 60045-4862

Is this the product you have?

  • Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
Lot codes and dates
  • Lot #348716 (exp. 12/2017)
Amount recalled
a) 62 tubes and b) 91 tubes

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications; out-of specification value for homogeneity / phase separation.

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

Notice updated May 10, 2019 · Data as of Sep 19, 7:11 PM UTC

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