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The Department of Health (DH) endorsed a licensed drug wholesaler, Amedis Company Limited (Amedis), to conduct voluntary recall of all batches of Inflexal V 2012/2013 seasonal influenza vaccine (registration number: HK-50625) (Inflexal influenza vaccine) from the market as a result of the global precautionary measure by the Swiss manufacturer, Crucell.
A DH spokesman said that Amedis informed DH that two batches of the product in the manufacturing site in Switzerland were found contaminated with bacteria. Crucell is investigating the root cause of the problem. As a precautionary measure, Crucell initiated a global recall of Inflexal influenza vaccines not yet officially released by the Swissmedic.
According to information available so far, only two batches of Inflexal influenza vaccines (lot no. 3000287.03 and 3000291.02) had been imported into Hong Kong and the risk of contamination of the two imported batches are remote. The two batches of Inflexal influenza vaccines were manufactured in August and were imported into Hong Kong in mid-September. The date of manufacture of the products in Hong Kong is different from the date of the manufacture of the two affected batches in Switzerland. The Certificate of Analysis showed that the products imported into Hong Kong had passed all quality tests, including sterility testings. DH has contacted the Swissmedic subsequently and confirmed that the imported two batches had been certified to be released into the market on September 18, 2012 and on September 24, 2012 respectively.
To meet the high demand of influenza vaccines in the coming influenza season, it is a special practice of the Swissmedic that influenza vaccines are allowed to be shipped to wholesalers when the vaccines have passed all quality tests under the Certificate of Analysis. However, they can only be sold to the market after the Swissmedic has officially signed the release certificates. A total of 21,071 boxes containing single injection of Inflexal influenza vaccines and 2,211 boxes containing 10 injections of Inflexal influenza vaccines were imported to Hong Kong pending notification from Crucell that the official release certificates have been issued. However, upon investigation, DH found that 3,179 boxes of single injection and 1,737 boxes of 10 injections had been sold to about 300 private doctors before receiving the notification. DH has already warned Amedis that notification of the official release certificate must be received before distribution of the product.
Based on the information available so far, it is considered that the potential risk of contamination of the two imported batches is remote. Nonetheless, DH considers the recall should be completed as scheduled according to international practice. DH urges that all doctors should co-operate with the recall and stop using the products and immediately return them to the wholesalers. However, people who had received the vaccines feel unwell, they should consult their doctors for assessment.
Amedis has set up a hotline at 8100 8606 to answer related enquiries. DH will closely monitor the recall. So far DH has not received any adverse reports in connection with the product.
Ends/Thursday, October 4, 2012
Issued at HKT 23:25
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