U.S. regulators have warned that the promotions Baxter Inc. made for its product, Tisseel surgical sealant, were misleading; Tisseel is a spray used to stop bleeding during surgery. The Food and Drug Administration (FDA) also believes many sales materials, such as brochures, overstated the sealant’s effectiveness and made unsubstantiated claims that it was superior to other competing products. The FDA has since asked the company to stop using misleading promotions and create a plan to disseminate information that would correct the previous false statements. Baxter is said to be working with the FDA to fix the problems.
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