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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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