The Recall Desk
HighFDA (Drugs)·D-1076-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

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