Other safety alerts
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| Australia: Substandard semaglutide vials |
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The Therapeutic Goods Administration (TGA) announces that it has tested a product, labelled ‘Semaglutide 2.64mg/ml, L-carnitine 100mg/ml B12 .05mg/ml solution for SC injection 3’, and found that:
- the vials contain ten times the amount of vitamin B12 (cyanocablamin) labelled.
- the content of L-carnatine, was estimated at 0.5-0.7mg/ml, well below the labelled 100mg/ml.
Consumers are advised that semaglutide is a prescription-only medicine in Australia.
The medicine, which purported to be compounded had solution within blue capped vials which was a distinctive red colour which is not the expected appearance, and was supplied to patients via regular mail, not purchased and dispensed from an Australian pharmacy.
Subcutaneous injection of this compounded semaglutide-like product is alleged to have resulted in the hospitalisation of a patient for peripheral neuropathy.
The product tested is not listed in the Australian Register of Therapeutic Goods and has not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation. The place of manufacture has not been determined. The compounding of semaglutide-like products by individuals who hold no formal qualifications and in unsterile environments poses a serious risk to human health.
Consumers are advised that if they have any concerns arising from their use of this or a similar medicine, consult their health care practitioner. If they suspect they have had a side effect to this or a similar medicine, retain the sample report it to the TGA.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/substandard-semaglutide-vials
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Apr 2, 2024
Issued at HKT 15:00
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