FDAClass IIMarch 11, 2020

Desoximetasone Topical Spray recall: Impurity Out of Spec

Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD

Why was Desoximetasone Topical Spray recalled?

Failed Impurities/Degradation Specification; high out of specification results observed

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?

K800475 exp. date May 2020 K800477 exp. date June 2020

Product
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
876 bottles
Distribution
Product was distributed throughout the United States.
Recall date
March 11, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls