Albuterol Sulfate Inhalation Solution Recalled for Temperature-Related Manufacturing Deviations
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Solution due to manufacturing deviations involving temperature abuse. The medication was 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: FDA Class II drug recall with manufacturing deviations affecting product stability. No illnesses or injuries have been reported, consistent with the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, due to manufacturing deviations involving temperature abuse during production.
This is a prescription inhalation medication. When exposed to improper temperatures during manufacturing, the product's stability and effectiveness may be compromised.
The recalled product was distributed nationwide to healthcare facilities and pharmacies. The manufacturer is unable to identify specific lot numbers for individual customers. Affected facilities should consult directly with McKesson or their pharmacy to determine if their product is included in this recall.
Healthcare providers and patients should discontinue use of the recalled product and consult with their pharmacist or physician regarding alternative medications.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Respiratory Medication
- Hazard
- temperature-abuse
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0304879501003
Distribution
Distributed nationwide across the United States.
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