Cardinal Healthcare recalls 60 x 3 mL vials of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution due to temperature exposure during storage. This may affect product stability and safety.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cardinal Healthcare is recalling Ipratropium Bromide and Albuterol Sulfate Inhalation Solution vials because they were exposed to temperatures outside the labeled storage conditions. This could affect product stability and safety.
The products were exposed to temperatures outside the labeled storage conditions during manufacturing. This could potentially affect the stability and safety of the medication, though the risk is not severe.
People who own or use the recalled inhalation solution vials are affected. Those with respiratory conditions may be at higher risk if the product is compromised.
Look for vials labeled 'Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials'. The NDC code 69097-840-64 and batch 21C56 are specific identifiers.
Verify the product label for the NDC code 69097-840-64 and batch number 21C56.
The recall is due to temperature exposure during manufacturing, which could affect product stability. However, the risk is low and does not cause serious injury.
Check for vials labeled 'Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials' with NDC 69097-840-64 and batch 21C56.
The recall does not specify a remedy, so contact Cardinal Healthcare for guidance on next steps.
We’ve drafted a message you can send Cardinal Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0161-2024 — Cardinal Healthcare Cardinal Healthcare Hello, I own a Cardinal Healthcare that is covered by recall D-0161-2024 from Cardinal Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
