Other safety alerts
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| Australia: Product safety and product recalls: Spiriva Respimat® Solution for Inhalation 2.5μg |
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Therapeutic Goods Administration (TGA) announces that Boehringer Ingelheim Pty Ltd is advising customers of a problem with some batches of the medicine, namely Spiriva Respimat® Solution for Inhalation 2.5μg (batch number: E96634, E63130, E61076), as there have been reports of the dosecounter stopping after the 10th dose and not locking after the 60th dose. The dose counter is still functional, and the device will continue delivering doses after the 10th dose, but the counter does not move any further. It remains as showing only 10 doses delivered.
The product is NOT being recalled, as this would lead to a shortage in the market. However, health professionals and patients need to be aware of this problem to ensure safe use and avoid harms.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/product-recalls/spiriva-respimatr-solution-inhalation-25mg
In Hong Kong, Spiriva Respimat Sol For Inhal 2.5mcg (HK-57639) is a pharmaceutical product registered by Boehringer Ingelheim (HK) Limited (Boehringer). It is a prescription-only medicine. As confirmed with Boehringer, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Jan 31, 2024
Issued at HKT 15:30
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