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Bayer has announced a voluntary recall of additional lots of Kogenate FS with vial adapter. This is an update to the recall that was issued on July 25, 2016. All lot numbers affected by the July 25, 2016 recall and August 10, 2016 extension are:

Product

Lot Number

Expiration Date

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
  • 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)

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.

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