Albuterol sulfate inhalation aerosol recalled for temperature storage deviation
Cardinal Healthcare recalls albuterol sulfate inhalation aerosol batch MY7E nationwide due to exposure to temperatures outside labeled storage conditions. The precautionary recall affects 2 cartons.
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 with no reported illnesses or injuries. The hazard is exposure to improper storage temperatures, which may affect product efficacy. Without hospitalization reports or confirmed harm, this is classified as Moderate per FDA guidelines for precautionary recalls.
Plain-English summary
Albuterol sulfate HFA inhalation aerosol 90 mcg per actuation (NDC 66993-019-68) manufactured by Prasco Laboratories for Cardinal Healthcare is being recalled. The product was exposed to temperatures outside the labeled storage conditions, a deviation from Good Manufacturing Practice (CGMP) standards.
The recall affects 2 cartons of batch MY7E distributed nationwide in the United States. Albuterol sulfate is a rescue medication used to treat asthma and other respiratory conditions.
The FDA classifies this as a Class II recall. Consumers with affected product should contact their pharmacy or healthcare provider. Do not use the product if you cannot confirm it was stored within the labeled temperature conditions.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- storage-temperature-deviation
- potential-efficacy-loss
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 MY7E
Distribution
Distributed nationwide across the United States.
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