Medicine recalls
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| Canada: Voluntary Recall of 2 Lots of AmBisome (liposomal amphotericin B for injection) - Risk of Bacterial Contamination - Notice to Hospitals |
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Health Canada announced that Astellas Canada has initiated a voluntary recall for two lots of AmBisome (liposome amphotericin B for injection); the lot numbers are 042269AA with expiry date 07/2015 and 0422C1AA with expiry date 11/2015. These lots may have been exposed to bacterial contaminant during the manufacturing process.
Gilead, Inc., the manufacturing partner, notified Astellas Pharma US, Inc. that during a routine simulation of the manufacturing processes and equipment used for the manufacturing of AmBisome, a bacterial contaminant was detected. A subsequent review of batch manufacturing records indicated that two affected lots of AmBisome were distributed in Canada from October 2012 through June 2013.
Please refer to the following website in Health Canada for details:http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../34277a-eng.php
In Hong Kong, AmBisome for INJ 50mg (HK-43591) are registered by LF Asia (Hong Kong) Limited - Healthcare Division and is a prescription-only medicine. The Department of Health (DH) endorsed LF Asia (Hong Kong) Limited - Healthcare Division, to conduct a voluntary recall of four batches (batch numbers: 042265AD, 042270AD, 042270AD1 and 042270AD2) of AmBisome for Injection 50mg from the market on 18 June 2013. So far, DH has not received any related adverse reports in connection with the product. News regarding the recall of AmBisome for INJ 50mg has been released by the Department of Health and was posted on the website of Drug Office on 18 June 2013.
The Department of Health has already contacted the LF Asia (Hong Kong) Limited - Healthcare Division for the additional affected batches and will keep vigilance on any safety updates on the above issue from Health Canada and other overseas regulatory authorities.
Related Information:
The United Kingdom: Class 1 Medicines recall (Action Now): Gilead Sciences International Limited is recalling AmBisome 50mg Powder for Solution for Infusion, due to a potential lack of sterility assurance (19/6/2013)
Batch recall of Ambisome for Injection 50mg (with photo) (18/6/2013)
Ends/Saturday, June 22, 2013
Issued at HKT 12:00
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