Albuterol Sulfate Inhaler Recalled Due to Manufacturing Temperature Deviations
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Aerosol HFA due to temperature exposure during manufacturing that caused deviations from manufacturing practice standards. The affected product was 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 FDA Class II recall affects a rescue medication (albuterol inhaler) where manufacturing deviations could reduce drug efficacy or stability. No illnesses or injuries are reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg strength with 200 metered inhalations per unit, manufactured for PAR Pharmaceutical. The recalled product consists of 5-unit aerosol packages that were distributed throughout the United States.
The recall was initiated due to temperature abuse during manufacturing that caused deviations from current Good Manufacturing Practice (cGMP) standards. Temperature exposure can compromise the integrity and performance of the medication.
If you have this albuterol inhaler, contact your pharmacy or healthcare provider to determine if your product is part of this recall. McKesson has notified customers individually with distribution dates and affected product shipment dates. Do not discard the medication without consulting a healthcare professional first; ask your provider about replacement options.
The recalled product
- Product
- Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Inhalation Aerosol
- Affected units
- 5
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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