Cardinal Health Recalls Levalbuterol Inhalers Due to Temperature Excursions
Cardinal Health is recalling 828 Levalbuterol tartrate HFA inhalers distributed in Florida, Georgia, and South Carolina 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 involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 828 units of Levalbuterol tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations. The product is distributed by Actavis Pharma, Inc. and carries the NDC 0591-2927-54. The recall is limited to units with code 200093.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers with this specific product should contact their healthcare provider or pharmacist for guidance on replacement or disposal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
- Brand
- LEVALBUTEROL TARTRATE HFA INHALATION
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhalation Aerosol
- Affected units
- 828
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)
- 200093
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.
See all 198 products in this recall →Related recalls
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