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
Product summary
- 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
out of specification