Medicine recalls
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| The United States: Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial |
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The FDA announced that Genzyme Corporation (a Sanofi Company) is initiating a voluntary recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial. This recall was initiated when one Thymoglobulin lot (C0072) failed a periodic stability test for the molecular size distribution test. Additional lots, manufactured with comparable quality of the raw material considered to be the root cause of the atypical stability trend, are being recalled based on the potential risk for a stability failure prior to end of shelf life for aggregation. No other Thymoglobulin lots are involved in this recall. Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issues directly associated with the stability failure. Please refer to the following link for a listing of lot numbers affected by this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/../ucm317127.htm
In Hong Kong, Thymoglobuline for IV Injection 25mg/5ml (HK-33039), containing anti-thymocyte immunoglobulins, is registered by Sanofi-Aventis Hong Kong Limited. The Department of Health has endorsed the recall of three affected batches with numbers C0074H29, C0088H10 and C0102H03 of Thymoglobuline for IV Injection 25mg/5ml from the market by Sanofi-Aventis Hong Kong Limited, because of the stability issue. Press release regarding the recall was issued on 3 August 2012. Related news has been released by MHRA and HSA and was posted on the website of Drug Office on 7 August and 23 August 2012.
Ends/ Wednesday, August 29, 2012
Issued at HKT 14:30 |
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