Public Advisory - Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials

OTTAWA, ON, March 18, 2023 /CNW/ -

• Product: Gilead Sciences, Inc., Cayston (Lots 032168 and 033357)
• Issue: Health product ? Product quality
• What to do: Check the lot number on your product or contact your pharmacist to determine whether your product is subject to this recall if you have any doubt. If you have a recalled product, stop taking the medication and contact your pharmacy immediately for a replacement product. If you become aware of any unusual symptoms or side effects that may be associated with this product, immediately contact your healthcare provider.
• Who this is for: General public

Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots (032168 and 033357) of the cystic fibrosis drug Cayston (aztreonam) (DIN 02329840) on March 1, 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 (0.17% sodium chloride) before inhaling it through a device (Altera Nebulizer System).

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. While the company continues to work with distributors and retailers to inform all affected individuals, Health Canada is communicating, as an additional measure, to mitigate any potential risk to health of Canadians. The Department is monitoring the company's recall and will inform the public if any new health risks are identified.

• Check the lot number on your product or contact your pharmacist to determine whether your product is subject to this recall if you have any doubt.
• If you have a recalled product, stop taking the medication and contact your pharmacy immediately for a replacement product. Return the affected product to your pharmacy for proper disposal.
• If you become aware of any unusual symptoms or side effects that may be associated with this product, immediately contact your healthcare provider.
• Contact Gilead Sciences, Inc., toll-free at 1-800-445-3235, or by e-mail at Safety_fc@gilead.com, if you have questions about this recall.
• Report any health product adverse events or complaints to Health Canada.

Alert / recall type: Public Advisory
Category: Health products ? Drugs
Published by: Health Canada

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SOURCE Health Canada