Albuterol Sulfate Inhalation Aerosol Recalled for Temperature Abuse During Distribution
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Aerosol nationwide due to temperature abuse during distribution that may affect drug stability.
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 for a prescription respiratory drug affected by temperature abuse during distribution. While no illnesses or injuries have been reported, the potential for compromised drug efficacy in a safety-sensitive medication represents a risk-of-harm situation warranting the High severity classification.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Albuterol Sulfate Inhalation Aerosol HFA 90 mcg with a dose indicator. The product is a prescription medication delivered by inhalation for respiratory use.
The recall was initiated due to current good manufacturing practice (cGMP) deviations caused by temperature abuse during product distribution. Temperature exposure may compromise the chemical stability and effectiveness of the medication. The FDA has classified this as a Class II recall.
The affected product was distributed nationwide. The manufacturer cannot identify specific lot numbers, but customers have been notified of the potential impact. Patients currently using this medication should contact their healthcare provider or pharmacist regarding whether their inhaler may be affected and to discuss alternative treatment options if necessary.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Respiratory Inhalation
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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