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Baxter recalls certain batches of Tisseel due to issues found during stability studies
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Gireesh Babu, New Delhi
September 04 , 2024
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Baxter (India), part of has US-based healthcare major Baxter, has informed about the voluntary recall of certain batches of its imported fibrin sealant VHS/D powder and solvent, branded as Tisseel LYO, used as an adjunct to hemostasis during surgery, due to some issues found during the stability studies.
The Office of the Drugs Controller General (India) (DCGI) has said that the company submitted a letter dated June 11, 2024 for urgent drug recall informing the problem, description, affected product, hazard involved, action to be taken by the customers and others. The DCGI publicised the drug recall on September 2, 2024, for the information and necessary action by the stakeholders.
Baxter has issued voluntary recall for the 4 ml and 10 ml Tisseel Fibrin Sealant Kits in two product codes, with six and one batches affected respectively, due to extended dissolution time of the sealer protein concentrate, observed during stability studies at storage temperature of 25 degree Celsius. The product is imported from the manufacturing facility Takeda Manufacturing Austria AG, in Austria.
The product codes with affected batches are 1504384 for 4 ml and 1505816 for 10 ml.
If the sealer protein concentrate is insufficiently dissolved, intraoperative delay in therapy could result while a fresh kit is being prepared.
"The likelihood that this would lead to harm for the patient is remote as Tisseel is an adjunct to hemostasis and sealing. Furthermore, as shown in laboratory testing, the product is still usable and effective even if the sealer protein is not completely dissolved," said the company.
All other quality parameters, including chemical and physical, comply with product specifications and no instances have been observed during testing where the sealer protein concentrate does not completely dissolve, it said.
The portion of the product that took longer to dissolve was around 1% and consists of fibrinogen, human albumin, and fibronectin, which are all part of the product composition. The company does not have replacement kigs for 4 ml and 10 ml Tisseel Lyo Fibrin Sealant Kits, it added.
The company said that healthcare providers may continue to safely use the products in the said product codes, if the fibrin sealant is prepared in advance to ensure it is fully dissolved and ready to be used when needed. If the Sealer Protein Concentrate has not fully dissolved within 20 minutes, discard the vial and prepare a fresh kit, it added.
If the consumer has unused kits that they would like to return, they can contact the Baxter Healthcare Centre for service to arrange for return and credit, it said. Once the company has implemented corrective actions to resolve the issue, a follow-up notification will be sent to customers to provide additional instructions, added the company.
According to information available, the Health Canada has in May, this year, announced that Baxter Corporation has recalled two lots of Tisseel kit from wholesalers and healthcare establishments as the dissolution time was out of specification in these lots.
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