Cardinal Healthcare recalls Spiriva Handihaler 18mcg capsules due to potential temperature exposure during storage. This may affect product stability and safety. Consumers should check NDC 0597-0075-41 batch 104440.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cardinal Healthcare is recalling Spiriva Handihaler inhalers that may have been exposed to temperatures outside the labeled storage conditions. This could affect product stability and safety, though the recall does not specify immediate health risks.
The inhalers may have been exposed to temperatures outside the labeled storage conditions during manufacturing or distribution. This could potentially affect the stability of the medication, though the recall does not specify immediate health risks.
People with prescriptions for Spiriva Handihaler 18mcg capsules (30 capsules per blister card) who received the specific NDC 0597-0075-41 batch 104440. Those using inhalers for respiratory conditions are most at risk if the product was exposed to improper temperatures.
Check for the NDC code 0597-0075-41 and batch number 104440 on the product packaging. The product is a 30-capsule blister card with 10 capsules per card, sold by Cardinal Healthcare.
Look for the NDC code 0597-0075-41 and batch number 104440 on the product packaging.
The recall does not specify immediate health risks, but the product may have been exposed to temperatures outside the labeled storage conditions, which could affect stability.
Check for the NDC code 0597-0075-41 and batch number 104440 on the product packaging. The product is a 30-capsule blister card with 10 capsules per card.
The recall does not specify a remedy, so contact Cardinal Healthcare directly for further instructions.
We’ve drafted a message you can send Cardinal Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0197-2024 — Cardinal Healthcare Cardinal Healthcare Hello, I own a Cardinal Healthcare that is covered by recall D-0197-2024 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.
