AstraZeneca Recalls Tudorza Pressair Inhalers Due to Defective Delivery System
AstraZeneca is recalling Tudorza Pressair inhalers because some units have actuation counters set to a number other than 60.
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 the defect involves a counter error rather than a direct physical hazard like fire or choking, fitting the criteria for moderate severity.
Plain-English summary
AstraZeneca Pharmaceuticals LP is recalling Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler. The recall involves 148,331 inhalers distributed nationwide, including Puerto Rico.
The recall is due to a defective delivery system where some units have actuation counters set to a number other than 60. The affected lots are # 1144394, # 1145539, and # 1145868, all with expiry dates in April or May 2018.
Consumers should stop using the affected inhalers and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spa
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Category
- Drug — Inhalation Powder
- Affected units
- 148,331
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 (5)
- Lot # 1144394
- Expiry: 04/2018
- Lot # 1145539
- Lot # 1145868
- Expiry: 05/2018.
Distribution
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