Company-led drug recall: Thymoglobuline (Anti-thymocyte globulin – rabbit) - Vials containing 25mg lyophilised powder - Genzyme Europe B. V. - CLDA(13)A05


The following section/document has been added/updated Title: Company-led drug recall: Thymoglobuline (Anti-thymocyte globulin – rabbit) - Vials containing 25mg lyophilised powder - Genzyme Europe B. V. - CLDA(13)A05 Summary Genzyme Europe B. V. have issued a recall because during stability studies, a batch has showed adverse trends in the molecular size distribution test. This batch is approaching the upper limit for polymers, aggregates and fragments.
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The following section/document has been added/updated

Title:

Company-led drug recall: Thymoglobuline (Anti-thymocyte globulin – rabbit) - Vials containing 25mg lyophilised powder - Genzyme Europe B. V. - CLDA(13)A05

Summary

Genzyme Europe B. V. have issued a recall because during stability studies, a batch has showed adverse trends in the molecular size distribution test. This batch is approaching the upper limit for polymers, aggregates and fragments.

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