FDAClass IIIAugust 31, 2016

Desoximetasone Gel USP recall: Impurity Out of Spec

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Why was Desoximetasone Gel USP recalled?

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

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?

Lot#: 1967800, Exp10/2016

Product
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
Recalling firm
Akorn, Inc.
Quantity
4,045 units
Distribution
Nationwide
Recall date
August 31, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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