FDAClass IIIFebruary 27, 2019

Clobetasol Propionate Emollient Cream 0.05% recall

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.…

Why was Clobetasol Propionate Emollient Cream 0.05% recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
Akorn Inc
Quantity
a) 4896 tubes; b) 5064 tubes
Distribution
Nationwide, including Puerto Rico.
Recall date
February 27, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls