Recalls / Class II
Class IID-0202-2024
Product
Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32
- Brand name
- Wixela Inhub
- Generic name
- Fluticasone Propionate And Salmeterol
- Active ingredients
- Fluticasone Propionate, Salmeterol Xinafoate
- Route
- Respiratory (inhalation)
- NDCs
- 0378-9320, 0378-9321, 0378-9322
- FDA application
- ANDA208891
- Affected lot / code info
- Batch 62002532
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm
- Firm
- CARDINAL HEALTHCARE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7200 Cardinal Pl W, Dublin, Ohio 43017-1094
Distribution
- Quantity
- 1 unit
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0202-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.