Recall of Thymoglobulin
Published: Aug 31, 2012
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that Genzyme initiated 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.
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