Additional Recall of Hemophilia A Drugs Announced

Follow-up recalls of antihemophilic drugs Kogenate FS and Helixate FS have been issued
Follow-up recalls of antihemophilic drugs Kogenate FS and Helixate FS have been issued

Bayer announced a voluntary recall of additional lots of Kogenate FS (antihemophilic factor VIII [recombinant]) as a follow-up to the safety communication issued on July 21, 2016. 

The July communication stated a recall of 2 lots of Kogenate FS 2000 IU Vial Adapter that contained an active ingredient manufactured prior to November 2015. The affected products had Lot #270R978 (Exp. 9/17/2017) and #270TN1C (Exp. 6/6/2018). 

An analysis was performed on other lots with active ingredient manufactured before November 2015 to assess whether there was a need for further action. After completing the analysis, Bayer has decided to voluntary recall other lots. Routine stability testing demonstrated that potency declined faster than expected in these lots. 

The potency for 2 additional lots of Kogenate FS 2000 IU Vial Adapter (Lot #270PWG8) and Kogenate FS 3000 IU BIO-SET (Lot #270NPV2) fell below the pre-specified acceptable range. These products are packaged in 5mL glass vials and are supplied in a shelf carton with either a BIO-SET or vial adapter; they were distributed between May 19, 2014 and Feb 23, 2015. The potency for an additional 8 lots of Kogenate FS 250 IU, 500 IU, 1000 IU, and 3000 IU Vial Adapter may eventually fall below the pre-specified acceptable range before shelf life expiry. 

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In addition, CSL Behring announced a voluntary recall of additional lots of Helixate FS (antihemophilic factor VIII [recombinant]) as a follow-up to the safety communication issued on July 21, 2016. The July communication stated a recall of 2 lots of Helixate FS 2000 IU that contained an active ingredient manufactured prior to November 2015. The affected products had Lot #270R979 (Exp. 9/17/2017) and #270TN1G (Exp. 6/6/2018). 

After an analysis on additional lots with active ingredient manufactured before November 2015, CSL Behring announced a recall of more lots. The affected products are packaged in 5mL glass vials and come in a shelf carton with Sterile Water for Injection, filter transfer set, and package insert. 

The potency for 2 lots of Helixate FS 2000 IU fell below the pre-specified acceptable range. In addition, the potency for another 41 lots of Helixate FS 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU may eventually fall below the pre-specified acceptable range before shelf life expiry. 

Kogenate FS and Helixate FS are both clotting factors indicated for use in hemophilia A patients.  

The Companies are asking customers to immediately quarantine inventory of the affected product under their direct control and to contact retail level customers to remove and return any affected inventory.

For more information visit FDA.gov.

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