Akorn, Inc. recalls Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Mariet…

Recall date

July 27, 2016

Source

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

Recall number

D-1469-2016

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide

Why it was recalled

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.