FLUTICASONE PROPIONATE Recall D-0182-2024
Description: Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
FLUTICASONE PROPIONATE Recall D-0182-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0182-2024 |
| Event ID | 89450 |
| Brand | FLUTICASONE PROPIONATE |
| Generic Name | FLUTICASONE PROPIONATE |
| Manufacturer | FLUTICASONE PROPIONATE |
| Original Package? | 1 |
| Active Substance | FLUTICASONE PROPIONATE |
| Drug Route | NASAL |
| Distribution | Nationwide USA |
| Quantity | 6 units |
| 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 | 60505-0829 |
| 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 |
| Drug Application Number | ANDA077538 |
| Structured Product Labeling (SPL ID) | 77643290-8a0d-2f0d-6ab1-f0bb58332418 |
| Structured Product Labeling (SPL Set ID) | 3830675d-b45e-fc97-1f73-674b1fc38c80 |
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