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 o

Recalled February 27, 2019 · FDA recall D-0515-2019 · Akorn

Hazard

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

Units

a) 4896 tubes; b) 5064 tubes

Sold at

Nationwide, including Puerto Rico.

Description

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

Product

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.

Manufacturer(s)

Akorn Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →