Medicine recalls
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| Canada: Apo-Mometasone nasal spray: Two lots recalled due to possible risk of infection |
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Health Canada announces that Apotex Inc. is recalling two lots of Apo-Mometasone nasal spray 50mcg/metered spray (lot number: TX5343, TZ2586) due to possible bacterial contamination with Burkholderia cepacia complex (Bcc). Bcc is a group of bacteria that poses a low medical risk to most healthy people; however, children, those with chronic lung diseases, people who are pregnant, seniors and those with a weakened immune system may be at a higher risk of illness.
The effects of Bcc vary widely, ranging from no symptoms at all to serious infections. In severe cases, Bcc can lead to bloodstream infections that may result in sepsis (a serious medical condition caused by an overwhelming immune response to an infection) and death. Bcc is often resistant to common antibiotics. People experiencing persistent or worsening symptoms, such as fevers, or facial pain or pressure, should seek medical attention.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apo-mometasone-nasal-spray-two-lots-recalled-due-possible-risk-infection
In Hong Kong, Apo-Mometasone Aqueous Nasal Spray 50mcg/metered spray (HK-62898) is a pharmaceutical product registered by Hind Wing Co Ltd (Hind Wing). The product is a prescription-only medicine.
On 16 Feb 2024, the Department of Health (DH) endorsed Hind Wing to recall one lot of Apo-Mometasone Aqueous Nasal Spray 50mcg/metered spray (HK-62898) (lot number: TX5343) from the market as a precautionary measure due to potential quality issue. A recall statement was posted on the Drug Office website on the same date.
As confirmed with Hind Wing, the other lot of product recalled in Canada (lot number: TZ2586) has not been imported into Hong Kong.
Related news was previously issued by Singapore Health Sciences Authority, and was posted on the Drug Office website on 16 Feb 2024.
Ends/Tuesday, Feb 20, 2024
Issued at HKT 14:30
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