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Information Letter on Carmubris® powder and solution for infusion (carmustine, 100 mg): Overfilled vial found

Active substance: carmustine

In the course of routine stability testing, an overfilled vial was found in a specific batch of Carmubris®. Such overfilled vials pose a significant risk of overdosing patients. No further overfilled vials were found. As a precaution, the marketing authorisation holder Bristol-Myers Squibb is recalling several batches of the medicinal product.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 239KB, File is accessible