Medicine recalls
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| Recall of Belkyra Solution for Injection 20mg／2ml |
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The Department of Health (DH) today (11 January) endorsed a drug registration holder, Allergan Hong Kong Limited (Allergan), to recall all batches of Belkyra Solution for Injection 20mg/2ml (Hong Kong Registration number HK-65660) from the market because the product’s label and package insert do not match with the registered ones.
The DH received notification from Allergan that during a product review conducted by the company, it was found that certain minor information on label and package insert of the above product was different from the registered version, which renders the product unregistered. Since supply of unregistered pharmaceutical product contravenes the Pharmacy and Poisons Regulations (Cap. 138A), Allergan voluntarily recalls the product from the market. DH's investigation is continuing.
The above product, containing deoxycholic acid, is a prescription medicine used to improve the appearance of moderate to severe fullness associated with submental fat (also known as double chin) when injected into tissue. According to Allergan, the product was distributed by a licensed wholesaler, DKSH Hong Kong Limited, and had been supplied to private doctors only.
So far, the DH has not received any adverse drug reaction report related to the affected product.
Allergan has set up a hotline (2610 5826) to answer related enquiries. The DH will closely monitor the recall.
Ends/Tuesday, 11 January , 2022
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