Genzyme recalls some kidney transplant drugs – Genzyme Corp. has recalled nine lots of thymoglobulin, a medication designed to treat acute kidney transplant rejection, according to the U.S. Food and Drug Administration.
The recall was initiated when one thymoglobulin lot failed a periodic stability test for the molecular size distribution test. The additional lots 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. The Cambridge-based biotechnology company 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.
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