The Recall Desk
ModerateFDA (Drugs)·D-1021-2022·Announced 2022-06-15

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.

What this means for you

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
  • 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 (1)

  • 0304870201018

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Same category