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| Canada: Recall: Spiriva Capsules; Out-of-specification (uniformity of delivered dose) (English only) |
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Health Canada announces that Boehringer Ingelheim Canada Ltd. is recalling 1 lot of Spiriva 18mcg capsule (Tiotropium bromide monohydrate) (lot number: 405636) from wholesalers due to out-of-specification (uniformity of delivered dose). The affected lot may not consistently provide the intended dose of medication with each use.
The product is indicated for long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/spiriva-capsules-out-specification-uniformity-delivered-dose
In Hong Kong, Spiriva Cap for Inhal 18mcg (Combopack) (HK-50663) and Spiriva Cap for Inhalation 18mcg (HK-51091) are pharmaceutical products registered by Boehringer Ingelheim (HK) Ltd (Boehringer Ingelheim). Both products are prescription-only medicines. As confirmed by Boehringer Ingelheim, the affected batch of Spiriva Capsules recalled in the above Health Canada announcement has not been imported into Hong Kong.
Ends/ Friday, Jun 26, 2026
Issued at HKT 15:00
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