Albuterol Sulfate Inhalation Solution Recalled Nationwide for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Solution nationwide due to temperature deviations during manufacturing that may have compromised product quality. No illnesses have been reported.
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: FDA Class II recall for a risk-of-harm respiratory medication subject to manufacturing process deviation (temperature abuse). No illnesses or injuries have been reported, but the potential for product quality compromise in a critical asthma/COPD medication justifies this severity classification.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Albuterol Sulfate Inhalation Solution 0.083% (2.5 mg/3mL) nationwide. The inhalation solution is packaged in 25 unit-dose vials and is manufactured by Nephron Pharmaceuticals Corporation (NDC 0487-9501-25).
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process. This deviation may have affected product quality or efficacy.
The affected product was distributed nationwide to healthcare facilities and pharmacies. McKesson Medical-Surgical is unable to identify specific lot numbers associated with individual customers, but has provided distribution dates to affected consignees.
No illnesses or adverse events have been reported. Patients currently using this medication should consult their pharmacist or healthcare provider about obtaining a replacement product or alternative asthma treatment.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Respiratory Medication
- Affected units
- 96
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.
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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