FLUTICASONE PROPIONATE Recall D-0202-2024
Description: 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
FLUTICASONE PROPIONATE Recall D-0202-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0202-2024 |
| Event ID | 89450 |
| Brand | WIXELA INHUB |
| Generic Name | FLUTICASONE PROPIONATE AND SALMETEROL |
| Manufacturer | FLUTICASONE PROPIONATE AND SALMETEROL |
| Original Package? | 1 |
| Active Substance | FLUTICASONE PROPIONATE SALMETEROL XINAFOATE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 0378-9320 0378-9321 0378-9322 |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | O2GMZ0LF5W 6EW8Q962A5 |
| Drug Application Number | ANDA208891 |
| Structured Product Labeling (SPL ID) | 03d33612-03b4-4a2c-ba86-47816db363ce |
| Structured Product Labeling (SPL Set ID) | 3beef422-8a07-4a45-9ba6-414511e4b7e2 |
| Similar To |