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Recall Observatory FDA recall evidence

Drug product

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

D-0866-2020

February 19, 2020

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 85015
Status
Terminated
Classification
Class II
Quantity
876 bottles
Official record key
drug-enforcement:D-0866-2020

Official wording

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

Code information: K800475 exp. date May 2020 K800477 exp. date June 2020

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification