Fluticasone Propionate Nasal Spray Recalled for Temperature Storage Deviation
Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a CGMP deviation due to temperature exposure. No illnesses, injuries, or adverse health events have been reported. The hazard is theoretical and precautionary in nature.
Plain-English summary
Cardinal Healthcare is recalling Fluticasone Propionate Nasal Spray USP (50MCG per spray) in response to Current Good Manufacturing Practice (CGMP) deviations discovered during product handling. The affected product was distributed nationwide.
The recall was initiated after products were found to have been exposed to temperatures outside the labeled storage conditions. This storage deviation represents a quality issue that may affect product stability and efficacy.
The affected product is Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, NDC 60505-0829-1. Batch codes TE9159 and TE8156 are involved. Patients currently using recalled product should consult their healthcare provider or pharmacist.
The recalled product
- Product
- FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
- Brand
- FLUTICASONE PROPIONATE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Nasal Corticosteroid
- Hazard
- temperature-exposure
- storage-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch TE9159
- TE8156
Distribution
Distributed nationwide across the United States.
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