Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured...
FDA Recall #D-0866-2020 — Class II — February 19, 2020
Product Description
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Reason for Recall
Failed Impurities/Degradation Specification; high out of specification results observed
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
876 bottles
Distribution
Product was distributed throughout the United States.
Code Information
K800475 exp. date May 2020 K800477 exp. date June 2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated