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

Recall date

November 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0152-2017

FDA classification

Class II

Brand / firm

Akorn Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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