Medicine recalls
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| Canada: Recall of six lots of Serophene Tab 50mg |
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EMD SERONO (A division of EMD INC., Canada) is recalling six lots of Serophene 50mg tablets (lot no.: S54009, S54011, S54012, S54013, S54015, S61003) due to the report of a new impurity (bromo analogue of Clomiphene Citrate) at above ICH specification (NMT 0.10%) level in API batches used in manufacture of Serophene 50mg tablets. The products were distributed to pharmacies, clinics and wholesalers.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../41271r-eng.php
In Hong Kong, Serophene Tab 50mg (HK-33272) is a pharmaceutical product registered by Merck Pharmaceutical (HK) Limited (Merck). Merck has informed the Department of Health (DH) of the voluntary recall of the four affected batches (S54009, S54013, S54015 and S54017) of the above product on 29 August 2014. Related news was released and posted on the Drug Office’s website on the same day. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to the product. The DH will closely monitor the recall.
Ends/ Wednesday, September 03, 2014
Issued at HKT 13:00
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