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.
Reason for recall: Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Recall initiated: 20190125
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated