Cardinal Health Recalls Proair HFA Inhalers Due to Temperature Excursions
Cardinal Health Inc. is recalling 26,895 Proair HFA inhalers due to intermittent exposure to temperature excursions during storage.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of reduced efficacy due to storage conditions, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 26,895 units of Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation. The product is marketed by Teva Respiratory, LLC and manufactured by IVAX Pharmaceuticals Ireland. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by lot code DAF02A. Distribution was limited to Florida, Georgia, and South Carolina. The recall is classified as Class II by the FDA.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhalation Aerosol
- Affected units
- 26,895
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)
- DAF02A
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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