Product Safety Recalls

Product Recall Tracker

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

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberD-0182-2024
Event ID89450
BrandFLUTICASONE PROPIONATE
Generic NameFLUTICASONE PROPIONATE
ManufacturerFLUTICASONE PROPIONATE
Original Package?1
Active SubstanceFLUTICASONE PROPIONATE
Drug RouteNASAL
DistributionNationwide USA
Quantity6 units
Recall ReasonCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Drug ClassificationClass II
Drug Code Info20240103
Product NDC60505-0829
Recall Initiation Date20220126
Report Date20240103
Classification Date20231226
Address7200 Cardinal Pl W
Dublin, OH 43017-1094
United States
Recalling FirmCARDINAL HEALTHCARE
Initial Notification Letter
Unique Ingredient IdentifierO2GMZ0LF5W
Drug Application NumberANDA077538
Structured Product Labeling (SPL ID)77643290-8a0d-2f0d-6ab1-f0bb58332418
Structured Product Labeling (SPL Set ID)3830675d-b45e-fc97-1f73-674b1fc38c80
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.