Prescription drug SPIRIVA recalled for temperature storage deviation
SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.
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 II recall with no reported illnesses or injuries and no documented evidence of actual product harm. The hazard is theoretical—potential loss of drug stability from temperature exposure—making this a precautionary manufacturing deviation recall.
Plain-English summary
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder), 18 mcg capsules, is being recalled due to manufacturing process deviations. The affected product is batch 104440, comprising 5 units distributed nationwide.
The recall was initiated because product in this batch was exposed to temperatures outside the storage conditions specified on the product label. This occurred during manufacturing and distribution, and may affect the product's stability and quality.
Consumers who have product from batch 104440 should contact their healthcare provider or pharmacist. Do not discontinue use of this medication without consulting your healthcare provider, as SPIRIVA is used to maintain control of chronic obstructive pulmonary disease.
The recalled product
- Product
- SPIRIVA (TIOTROPIUM BROMIDE)
- Brand
- SPIRIVA
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- improper-storage-temperature
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch 104440
Distribution
Distributed nationwide across the United States.
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