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.

Recall Number: D-0515-2019

Firm: Akorn Inc

Classification: Class III

Status: Terminated

Report Date: 20190227

Initiation Date: 20190125

Termination Date: 20201103

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

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.