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  1. Safety & Availability (Biologics)

Voluntary Drug Recall Extension - Kogenate FS Antihemophilic Factor (Recombinant)

Voluntary Drug Recall Extension - Kogenate FS Antihemophilic Factor (Recombinant)

DATE RECALL INITIATED: August 11, 2016

MANUFACTURER:

Bayer HealthCare LLC
Berkeley, CA

REASON:

Bayer is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Kogenate® FS containing active ingredient manufactured before November 2015.

The lots communicated on July 21, 2016 are:

Product Lot Number NDC Number Expiry Date
KOGENATE FS 2000 IU VIAL ADAPTER 270R978 0026-3786-65 09/17/2017
KOGENATE FS 2000 IU VIAL ADAPTER 270TN1C 0026-3786-65 06/06/2018

Bayer has conducted an analysis of additional lots with active ingredient manufactured before November 2015 to determine if there was a need for further action. The analysis is now complete and, as a result, Bayer is voluntarily recalling additional lots.

Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. The material is packaged in 5mL glass vials and comes in a shelf carton with either a BIO-SET or vial adapter as indicated in the tables below.

In two lots distributed between May 19, 2014 and February 23, 2015, potency levels fell below the pre-specified acceptable range. These two lots are:

Product Lot Number NDC Number Expiry Date
KOGENATE FS 2000 IU VIAL ADAPTER 270PWG8 0026-3786-65 05/08/2017
KOGENATE FS 3000 IU BIO-SET 270NPV2 0026-3797-70 08/17/2016

In eight lots distributed between June 9, 2015 and August 2, 2016, potency may eventually fall below the pre-specified acceptable range before shelf life expiry. ("Additional Lots Subject to Recall").

Additional Lots Subject to Recall:

Product Lot Number NDC Number Expiry Date
KOGENATE FS 250 IU VIAL ADAPTER 270RV8X 0026-3782-25 12/19/2017
KOGENATE FS 250 IU VIAL ADAPTER 270TN10 0026-3782-25 06/04/2018
KOGENATE FS 500 IU VIAL ADAPTER 270R70V 0026-3783-35 08/27/2017
KOGENATE FS 500 IU VIAL ADAPTER 270RJ5L 0026-3783-35 11/23/2017
KOGENATE FS 500 IU VIAL ADAPTER 270T306 0026-3783-35 01/29/2018
KOGENATE FS 500 IU VIAL ADAPTER 270TG7L 0026-3783-35 03/25/2018
KOGENATE FS 1000 IU VIAL ADAPTER 270TWOR 0026-3785-55 07/8/2018
KOGENATE FS 3000 IU VIAL ADAPTER 270TTR6 0026-3787-75 06/22/2018

Bayer is asking customers to immediately quarantine inventory of the affected product under their direct control and to contact retail (pharmacy) level customers to have the identified product removed from pharmacy inventories and returned.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.