Friday, August 12, 2016
Clarification of Voluntary Recalls Issued for Kogenate FS & Helixate FS
August 11, 2016
Upon clarification by the manufacturers of Kogenate FS (Bayer) and Helixate FS (CSL Behring), it has come to HFA's attention that ALL of the lot numbers listed below are included in the extension recalls issued on August 10, 2016 and the original recall notice of July 25, 2016.
This is not an issue of safety of the product. Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. Product you may have from the these affected lots can be returned for replacement.
HFA encourages everyone to take action to be informed. Sign up for the Patient Notification System (PNS). If a therapy is withdrawn or recalled, the PNS system notifies those registered within 24 hours.
PNS is a fast, free, and confidential program that alerts patients with hemophilia, von Willebrand Disease, and other bleeding disorders of a withdrawal or recall of therapy products. All major plasma-derived and recombinant analog therapy manufacturers participate in this system.
All Lot Numbers Affected by Recall
Listed by Product Name, Assay Size and Date of Recall Issued
Recall Initiated on July 21, 2016
Recall Extended on August 10, 2016
Recall Extended on August 10, 2016 (Clarification provided by manufacturers on August 12, 2016 that these lot numbers are INCLUDED in recall extension dated August 10, 2016)
BAYER: Kogenate FS
|Kogenate FS 250 IU Vial Adapter||270RV8X||12/19/2017|
|Kogenate FS 250 IU Vial Adapter||270TN10||06/04/2018|
|Kogenate FS 500 IU Vial Adapter||270R70V||08/27/2017|
|Kogenate FS 500 IU Vial Adapter||270RJ5L||11/23/2017|
|Kogenate FS 500 IU Vial Adapter||270T306||01/29/2018|
|Kogenate FS 500 IU Vial Adapter||270TG7L||03/25/2018|
|Kogenate FS 1000 IU Vial Adapter||270TW0R||07/08/2018|
|Kogenate FS 2000 IU Vial Adapter||270R978||09/17/2017|
|Kogenate FS 2000 IU Vial Adapter||270TN1C||06/06/2018|
|Kogenate FS 2000 IU Vial Adapter||270PWG8||05/08/2017|
|Kogenate FS 3000 IU Vial Adapter||270TTR6||06/22/2018|
|Kogenate FS 3000 IU Bio-Set||270NPV2||08/17/2016|
This is not an issue of safety of the product. Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. For further information or to arrange for an exchange, please contact Bayer at 1-888-84-BAYER (1-888-842-2937)
Bayer will be engaging the Patient Notification System (PNS) to notify all registrants and is notifying customers. For those of you signed up with PNS, you will receive additional notification from PNS/SteriCycle, Inc.
Click here for the full notification from Bayer.
CSL Behring: Helixate FS
It is important to note these are not FDA mandated recalls and should not be considered product safety issues.
PATIENT NOTIFICATION SYSTEM
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