The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1024-2022·Announced 2022-06-15

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.

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 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
Affected units
1

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.

See all 130 products in this recall →

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