WFH NETWORK

Alert on the use of vials of water for injection (2.5ml, 5ml and 10ml) included in some LFB BIOMEDICAMENTS products

Please note that LFB BIOMEDICAMENTS has issued an alert concerning a defect in the quality appearance of the water for injection (vials 2.5ml, 5ml and 10ml) which is packaged in the products listed below. LFB BIOMEDICAMENTS has requested not to use the vial of water for injection which is packed in the same box as the freeze-dried product. In France, hospitals have been advised to reconstitute the freeze-dried powder with another vial of water for injection, different to the one provided by LFB, available in the hospital with the same format. No alternative diluent except water for injection can be used.

There have been no pharmacovigilance cases or complaints related to this defect reported to date. All of the results of release tests for all of the concerned batches of water for injection are compliant. Because the quality of the freeze-dried powder is not concerned, the vials of freeze-dried product are not subject to this alert.

This quality appearance defect may be due to the presence of translucent particles on the scale of the micron, which may appear randomly over time. As a precautionary measure, LFB BIOMEDICAMENTS has changed the vials of water for injection with new batches of 10ml and 5ml vials for future manufactured batches.

All patients who received such products should contact their hemophilia treatment centre (HTC) which should have already been informed.

Products

Country


WILFACTIN 100 UI/ml, powder and solvent for injection – 1000 UI/10 ml

Belgium, Algeria, Finland, UK, Greece, Italy, Kuwait, Libya, Morocco, Mexico, Netherlands, Russia


BETAFACT 50 UI/ml, powder and solvent for injection – 500 UI/10 ml

Brazil, Colombia, Greece, Mexico, Turkey


BETAFACT 50 UI/ml, powder and solvent for injection – 250 UI/5 ml

Algeria, Tunisia


BETAFACT 100 UI/ml, powder and solvent for injection – 500 UI/5 ml

Algeria, Lebanon


BETAFACT 100 UI/ml, powder and solvent for injection – 1000 UI/10 ml

Algeria


FACTANE 100 UI/ml, powder and solvent for injection – 500 UI/5 ml

Brazil, Colombia, Lebanon, Turkey


FACTANE 100 UI/ml, powder and solvent for injection – 250 UI/2.5 ml

Mexico


FACTANE 100 UI/ml, powder and solvent for injection – 1000 UI/10 ml

Belgium, Turkey


FACTANE 200 UI/ml, powder and solvent for injection – 1000 UI/5 ml

Kuwait, Tunisia


FACTANE 200 UI/ml, powder and solvent for injection – 2000 UI/10 ml

Kuwait, Morocco, Tunisia


HEMOLEVEN 100 UI/ml, powder and solvent for injection 1000 U/10 ml

Germany, Belgium, Spain, Switzerland, Colombia, Italy, Luxembourg, Netherlands, Saudi Arabia, U.K.