Ipratropium Bromide and Albuterol Sulfate inhalation solution recalled for temperature abuse
McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is a cGMP deviation due to storage conditions rather than confirmed product failure. Class III recalls are typically scored 1-2 per the severity rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, a combination respiratory medication delivered via 3mL vials. The recall was initiated due to cGMP deviations that resulted from temperature abuse during product storage.
The recalled products are packaged in two formats: 30-count vials (NDC 0487-0201-03) and 60-count vials (NDC 0487-0201-60), manufactured by Nephron Pharmaceuticals Corporation. The recall affects 56 pouches and was distributed nationwide across the United States. McKesson reports that it is unable to identify specific lot numbers at the distribution point to individual customers; instead, customers have been notified by distribution date.
No illnesses or injuries have been reported in connection with this recall. Patients currently using this medication should consult their healthcare provider or pharmacist about their specific supply. Healthcare facilities and pharmacies should check their inventory against the distribution dates provided by McKesson and cease dispensing the affected product.
The recalled product
- Product
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
- Brand
- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Respiratory Inhalation
- Hazard
- Affected units
- 56
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)
- 0304870201018
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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