FDA recall D-0866-2020

Lupin Pharmaceuticals Inc. · Class II · drug

Product

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

Distribution

Product was distributed throughout the United States.

Key facts

Status
Terminated
Initiation date
2020-02-19
Report date
2020-03-11
Termination date
2021-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2020