Recalls / Class II
Class IID-0374-2022
Product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
- Affected lot / code info
- a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Ingenus Pharmaceuticals Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4190 Millenia Blvd, N/A, Orlando, Florida 32839-6408
Distribution
- Quantity
- 45,173 cans
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-01-10
- FDA classified
- 2022-01-14
- Posted by FDA
- 2022-01-26
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0374-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.