97 Baxter recall letter for Product Fibrin Sealant Kit Brand name Tisseel Lyo manufactured in Vienna Austria 2024-Sep-02 1508 KB

Directorate General of Health Services Office of Drugs Controller General (India) (Blood Product)

(Biological Division)

To

File No. PAC/BP/19/Baxter/Voluntary recall of Fibrin sealant kit Tisseel Lyo/2024-BD

;

FDA Bhawan, Kotla Road, New Delhi, 11Q002 Dated: t) 2 SEP 2074

All Stake Holders/General Public

Public Notice Subject: Voluntary Recall (Grade Ill) Notification for the Product Generic Name: Fibrin Sealant VHS/D powder and solvent for Sealant |.P. Name: Tisseel LYO from the manufacturing facility Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221, Vienna, Austria-reg.

Reference: Firm Letter no. BAX/AS/CDSCO/2024/058 dated 19.06.2024 and E. NO. 41359.

Sir,

With reference to letter cited above on the subject matter wherein the Firm M/s Baxter (India) Pyt. Ltd, 5 Floor, Tower A, Building No. 9, DLF Cyber City, DLF phase Ill, Gurgaon-122002, Haryana, India has informed about the voluntary recall of imported product Generic Name: Fibrin Sealant VHS/D powder and solvent for Sealant |.P. Name: Tisseel LYO imported from the manufacturing facility Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221, Vienna, Austria.

| M/s Baxter Healthcare Corporation has issued a voluntary recall for the 4 mL and 10 mL Tisseel Fibrin Sealant Kits listed below due to extended dissolution time of the sealer protein concentrate, observed during stability studies at storage temperature of 25°C.

All other quality parameters (chemical and physical) comply with product specifications and no instances have been observed during testing where the Sealer Protein concentrate does not completely dissolve. The portion of the product that took longer to dissolve was approximately 1% and consists of fibrinogen, human albumin, and fibronectin, which are all part of the product composition. Firm does not have replacement kits for the 4 mL and 10 mL Tisseel Lyo Fibrin Sealant Kits.

The impacted lots detail is as below:

|Product<br>Code|ProductName|Packsize | Affected<br>Batch No.|Packsize | Affected<br>Batch No.|Quantity |Quantity<br>Imported |Available<br>Warehouse|Quantity |Quantity<br>Imported |Available<br>Warehouse|in|
|---|---|---|---|---|---|---|
|1504384|Fibrin Sealant <br>powder<br>and<br>for Sealant |.P.|VHS/D| 4 ml<br>solvent|T5A010AA<br>T5A047AC<br>T5X053AD|3112<br>2685<br>3120|||
||||T5X056AD|3120|||
||||T5X075AA|3119|||
|1505816|Fibrin Sealant|VHS/D| 10 ml|T5X036AE|62|43||
||powder<br>and|solvent|||||
||forSealant|.P.||||||

Further, Firm submitted letter dated 11.06.2024 for urgent Drug Recall informing the Pro’ 3m Description, affected product, hazard Involved, Action to be taken by Customers. (Copy enclos.d). This is for the information and necessary action.

Yours faithfully

GH RAGHUVANSHI) DRUGS CONTROLLER GENERAL (INDIA)

Copy to: CDSCO Website for information.

Urgent Drug Recall

Jun 11, 2024

Dear Healthcare Provider or distributor:

Problem Baxter Healthcare is issuing an Urgent Drug Recall for the 4 mL and 10 mL Tisseel Fibrin Description Sealant Kits (commonly referred to as Tisseel Lyo fibrin sealant), listed below due to extended dissolution time of the sealer protein concentrate, observed during stability studies at storage temperature of 25°C.

All other quality parameters (chemical and physical) comply with product specifications and no instances have been observed during testing where the Sealer Protein concentrate does not completely dissolve. The portion of the product that took longer to dissolve was approximately 1% and consists of fibrinogen, human albumin, and fibronectin, which are all part of the product composition.

Baxter does not have replacement kits for the 4 mL and 10 mL Tisseel Lyo Tisseel Fibrin Sealant Kits. Healthcare providers may continue to safely use the products listed below 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 min, discard the vial, and preparea fresh kit.

==> picture [401 x 82] intentionally omitted <==

----- Start of picture text -----<br> Distribution of the impacted product began on 06 Aug 2022 in India.<br>Affected Product Product Description Lot Number<br>Product Code<br>4504384 TISSEEL ig gs SA 4ML See attachment A<br>1505816 TISSEEL KIT,VHSD,SA,10ML<br>----- End of picture text -----<br>

Hazard if the sealer protein concentrate is insufficiently dissolved, intraoperative delay in therapy Involved 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. Tisseel is intended for epilesional use only; it is not to be used intravascularly.

Actions to be taken by Customers

• As of 05/22/2024, Baxter has not received any confirmed complaints or adverse events reported associated with this issue on the impacted products. 1. Healthcare providers may continue to safely use the products listed above 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, discard the vial, and prepare a fresh kit.

2. If you have unused Tisseel Fibrin Sealant Kits that you would like to return, contact Baxter Healthcare Center for Service to arrange for return and credit.

3. Once Baxter has implemented corrective actions to resolve the issue, a follow-up notification will be sent to customers to provide additional instructions.

4. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by scanning and e-mailing it to Baxter sales team or india product complaints@baxter.com. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices,

FA-2024-032

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Fo owter

centin tha Sesnc ee ES ICI. Clinician comments on units that were affected: No comments from° Clinician yet, however based on the FA letter sent to the impacted customers, if there are any comments we will update your good offices. available.Currently, investigation is ongoing to determine the root cause and further information will be provided once Please be assured of our full cooperation for any additional information that may be required.

Thank you.

Yours sincerely,

For Baxter (India) Pvt. Ltd.

p> DeshmukhElectronically signed by: Deepali Reason: | approve this document . Date: Jun 20, 2024 09:16 GMT+5.5

Deepali Deshmukh Senior Manager — Quality & Regulatory Affairs Deepali_ingle@baxter.com Mobile: 9971500722

Enclosure:

Copy of Healthcare provide/distributer communication letter.

Baxter (India) Pvt. Ltd. CIN:- U33112HR1996PTC038528 Registered Office : 5th Floor, Tower A, Building No. 9, DLF Cyber City, DLF Phase - II|, Gurgaon - 122002, Haryana, India T 91-124-450.0200 E baxterindia@baxter.com W www.baxter.in