Albuterol sulfate inhalation solution recalled for manufacturing temperature-abuse defect
McKesson Medical-Surgical is recalling albuterol sulfate inhalation solution 0.021% (0.63 mg/3mL vials) distributed nationwide. The FDA Class II recall is due to cGMP deviations involving temperature abuse.
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 recall for cGMP deviations with no reported illnesses or injuries. Temperature abuse of a respiratory medication presents potential risk to drug efficacy but falls below Class I or evidence of harm that would justify higher severity scores.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling albuterol sulfate inhalation solution, 0.021% strength, supplied as 0.63 mg/3mL in sterile unit-dose vials. This is a prescription respiratory medication used to treat asthma and breathing conditions.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. Because McKesson was unable to identify which specific lot numbers reached individual customers, each notification included the distribution date and estimated shipment dates of potentially affected product.
This product was distributed nationwide. Patients should contact their healthcare provider or pharmacist with questions about their medication. Healthcare providers and pharmacies should quarantine remaining inventory and follow instructions from the FDA and McKesson for product return or disposal.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Inhalation
- Hazard
- manufacturing-defect
- temperature-abuse
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0304879904019
- 0304870301015
Distribution
Distributed nationwide across the United States.
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