Akorn Inc recalls Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx…

Recall date

January 25, 2019

Source

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

Recall number

D-0515-2019

FDA classification

Class III

Brand / firm

Akorn Inc

Sold / distributed

Nationwide, including Puerto Rico.

Why it was recalled

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

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

What was recalled

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.