Cardinal Health Recalls Flovent Diskus Inhalers Due to Temperature Excursions
Cardinal Health Inc. is recalling 237 units of Flovent Diskus 100mcg inhalers due to intermittent temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard involves a storage condition (temperature excursion) that is a potential quality issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 237 units of Flovent Diskus 100mcg inhalers (NDC 173060202) due to deviations from Current Good Manufacturing Practices (CGMP). The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.
The affected units were distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is 9E9A.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhaler
- Affected units
- 237
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)
- 9E9A
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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