Medicine recalls
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Recall 4 batches of Serophene 50mg Tablet |
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The Department of Health (DH) today (August 29) endorsed a licensed drug wholesaler, Merck Pharmaceutical (HK) Ltd. (Merck), to conduct a voluntary recall of four batches (S54009, S54013, S54015 and S54017) of Serophene tablets 50mg (registration number: HK-33272) from the market due to potential quality issue.
The DH received notification from Merck that the Israel manufacturer of the product had found the above 4 batches of the product were manufactured with raw material found to contain impurity. Although there is no evidence that the impurity in question would have adverse effects on health, Merck has decided to recall the affected batches from the market as a precautionary measure. So far, the DH has not received any adverse reports in connection with the product. The DH has requested Merck to provide a detailed investigation report as soon as possible.
Investigation is continuing.
Serophene tablet 50mg, containing clomiphene citrate, is a prescription medicine used for the treatment of infertility due to ovulation difficulty.
According to Merck, the affected batches were imported into Hong Kong between January 2012 and May 2013, and they had been supplied to private hospitals, private doctors and pharmacies.
Merck has set up a hotline on 2170 7737 to answer public enquiries. The DH will closely monitor the recall.
"Healthcare providers should stop supplying the affected product to their clients. Members of the public who are consuming the product should consult their healthcare professionals if in doubt" a DH spokesman advised. |
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