Recalls / Class II
Class IID-0866-2020
Product
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
- Affected lot / code info
- K800475 exp. date May 2020 K800477 exp. date June 2020
Why it was recalled
Failed Impurities/Degradation Specification; high out of specification results observed
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 876 bottles
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2020-02-19
- FDA classified
- 2020-03-03
- Posted by FDA
- 2020-03-11
- Terminated
- 2021-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0866-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.