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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D Powder and solvent for sealant by Baxter. The imported product is manufactured by Takeda in Vienna, Austria. The recall is is due to extended dissolution time of the sealer protein concentrate observed during stability studies. Baxter is recalling six batches of 4ml and 10ml Tissel Fibrin Sealant Kits. Tisseel is an adjunct to hemostasis and sealing to help surgeons address bleeding in sites inaccessible to “surgical” means (i.e., sutures and cautery). The likelihood of the product causing harm to patients is remote and Baxter has not received any confirmed complaints or adverse events on the issue.
CDSCO Drug Alert for Tisseel Lyo Fibrin Sealant VHS/D Powder and solvent
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