Boehringer Ingelheim Recalls Defective Combivent Respimat Inhalers
Boehringer Ingelheim is recalling 358,647 Combivent Respimat inhalers because the delivery system may fail to spray properly.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling 358,647 units of COMBIVENT RESPIMAT (ipratropium bromide and albuterol) inhalation spray. The affected product is identified by Lot # 408267 and an expiration date of 11/17. The recall covers units distributed nationwide and in Puerto Rico.
The recall is being issued because the inhalers have a defective delivery system. The devices may not spray properly, resulting in either no spray or a short transient spray. This defect prevents the medication from being delivered as intended.
Consumers who have this specific lot of COMBIVENT RESPIMAT should stop using the product and contact their healthcare provider or pharmacist for a replacement. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL)
- Brand
- COMBIVENT RESPIMAT
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Inhalation Spray
- Affected units
- 358,647
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 (2)
- Lot #: 408267
- Exp 11/17
Distribution
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