Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2015
Seprafilm off-label marketing settlement
Genzyme accepted responsibility and agreed to pay approximately $32.59 million to resolve U.S. allegations concerning promotion of an unapproved laparoscopic slurry application of Seprafilm. A separate civil agreement related to the marketing allegations had been reached in 2013.
2009
Manufacturing contamination and product-quality failures
Viral contamination at Genzyme facilities in Belgium and Massachusetts, together with foreign material found in some drug batches, caused shutdowns, reduced output, and shortages of important medicines. Regulators permitted some products to remain available because patients had few alternatives, but the incidents generated significant scrutiny.