FDA Drug Class III — Least Serious

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.

Hazard

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

Products

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.
UPC
a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19

Units Affected

a) 4896 tubes; b) 5064 tubes