Reported Jan 3, 2024 · Terminated

SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card…

Cardinal Healthcare

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CARDINAL HEALTHCARE · 7200 Cardinal Pl W · Dublin, OH · 43017-1094

Is this the product you have?

  • SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only
  • Distributed byBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
  • NDC0597-0075-41
Lot codes and dates
  • Batch 104440
Amount recalled
5 units

This recall covers 42 products

The agency filed one notice per product. You are reading one of them; the other 41 are below.

29 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 29, 2024 · Data as of Sep 19, 8:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.