FDA Recalls Proair HFA Albuterol Inhalation Aerosol for Temperature Abuse
The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries and no confirmed harm from temperature exposure. The hazard involves manufacturing deviations affecting product stability, which represents a risk-of-harm scenario without documented adverse events, placing it in the High severity category.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling 56 units of Proair HFA (albuterol sulfate) inhalation aerosol 90 mcg per actuation, manufactured by Teva Pharma USA (NDC 59310-579-22). The recall was initiated due to cGMP deviations identified during manufacturing, specifically temperature abuse.
The recalled product was distributed nationwide throughout the United States. The recalling company is unable to identify specific lot numbers for the products received by particular customers. However, distribution letters to customers indicate the dates each shipment was made and the time period during which affected product may have been sent to them.
This recall has been classified as FDA Class II.
The recalled product
- Product
- Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Inhalation Aerosol
- Affected units
- 56
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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