Cardinal Health Recalls Spiriva Inhalers Due to Temperature Excursions
Cardinal Health Inc. is recalling 2,611 units of Spiriva HandiHaler inhalers due to intermittent exposure to temperature excursions during storage.
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: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 2,611 units of Spiriva HandiHaler (tiotropium bromide inhalation powder) 18 mcg capsules. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific NDC for the recalled product is 0597-0075-41, and the code information is 5098. The product is manufactured by Boehringer Ingelheim (BI) Pharma GmbH & Co. KG and marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer, Inc.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SPIRIVA (TIOTROPIUM BROMIDE)
- Brand
- SPIRIVA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Inhalation Powder
- Affected units
- 2,611
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)
- 5098
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
Same brand · SPIRIVA
- ModeratePrescription drug SPIRIVA recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
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FDA (Drugs) · 2018-02-07
- LowBoehringer Ingelheim Recalls Spiriva HandiHaler Due to Defective Delivery System
FDA (Drugs) · 2014-04-16
- ModerateBoehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Foreign Particles
FDA (Drugs) · 2013-09-25
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