FDA recalls Asmanex asthma inhalation powder for improper storage conditions
Cardinal Healthcare is recalling Asmanex Twisthaler inhalers (batch U027458) because they were exposed to temperatures outside their labeled storage conditions. The FDA classified this as a Class II recall due to the manufacturing deviation.
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 FDA Class II recall is based on a manufacturing deviation (temperature exposure outside labeled storage conditions) with no reported illnesses or injuries. The recall is precautionary in nature.
Plain-English summary
Cardinal Healthcare is recalling a specific batch of Asmanex Twisthaler inhalation powder (mometasone furoate, 220 mcg per actuation), batch U027458. The recall was initiated because the affected units were exposed to temperatures outside the labeled storage conditions during manufacturing or distribution.
This product is an Rx-only asthma maintenance medication manufactured for Organon LLC. The affected batch consists of 3 units distributed nationwide in the United States.
The FDA has classified this as a Class II recall due to the manufacturing deviation. Patients who have this specific batch should contact their pharmacy or healthcare provider with questions about whether their medication was affected.
Do not stop using your asthma medication without consulting your healthcare provider first, as these are essential maintenance medications. Your healthcare provider can advise you on whether your specific medication is part of the recalled batch and recommend any appropriate next steps.
The recalled product
- Product
- ASMANEX (MOMETASONE FUROATE)
- Brand
- ASMANEX
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Inhaled Corticosteroid
- Hazard
- storage-temperature-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 (1)
- Batch U027458
Distribution
Distributed nationwide across the United States.
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