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| Canada: Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials (English only) |
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Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots of the cystic fibrosis drug Cayston (aztreonam) (lot number: 032168 and 033357) on 1 Mar 2023, due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication. A cracked glass vial could cause potential injury or lead to potential contamination or a reduced dose.
Cayston is a prescription antibacterial medicine used for the management of chronic infections in cystic fibrosis patients. It is a powder that needs to be reconstituted by adding a sterile diluent before inhaling it through a device.
Product contamination may lead to localized lung infections, such as pneumonia, or systemic complications, such as bacterial sepsis. Patients with weakened immune systems or abnormal lung function, such as those with cystic fibrosis, may be at higher risk. Glass particles in Cayston may cause local tissue irritation, and may lead to local tissue infections, or abscesses, if undiagnosed. A reduced dose or reduced efficacy may worsen the health status of patients under treatment, due to not controlling chronic infections.
The manufacturer has not received any customer complaints in relation to cracked glass vials in the recalled lots, or any other Cayston lots distributed in Canada.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/two-lots-cystic-fibrosis-drug-cayston-recalled-due-potential-cracked-glass-vials
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 4 Mar 2023.
Ends/Monday, Mar 20, 2023
Issued at HKT 13:00
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