Peritoneal dialysis solutions

Replacement | Medicines | 27/04/2011

Baxter Healthcare has identified elevated levels of endotoxin in some batches of the above peritoneal dialysis solutions at its manufacturing facility in Castlebar, Ireland, posing a risk of aseptic peritonitis. Since December 2010, five batches have already been recalled from the market. Since sufficient replacement products are now available, all remaining units of the above-mentioned peritoneal dialysis solutions produced in Castlebar, which can be identified by the article code, will be exchanged. The marketing authorization holder has informed its supplied customers of this in a letter dated April 26, 2011.

Name of the medicinal product 1. Dianeal PD1 Glucose 1,36 % w/v /13,6 mg/ml – Peritonealdialyselösung
2. Dianeal PD1 Glucose 2,27 % w/v /22,7 mg/ml – Peritonealdialyselösung
3. Dianeal PD1 Glucose 3,86 % w/v /38,6 mg/ml – Peritonealdialyselösung
4. Dianeal PD4 Glucose 1,36 % w/v /13,6 mg/ml – Peritonealdialyselösung
5. Dianeal PD4 Glucose 2,27 % w/v /22,7 mg/ml – Peritonealdialyselösung
6. Dianeal PD4 Glucose 3,86 % w/v /38,6 mg/ml – Peritonealdialyselösung
7. Extraneal – Peritonealdialyselösung
8. Nutrineal PD4 mit 1,1% Aminosäuren – Peritonealdialyselösung
Marketing authorisation number(s) 1. 1-20117
2. 1-20118
3. 1-20119
4. 1-21583
5. 1-21585
6. 1-21584
7. 1-22174
8. 1-23686
Marketing authorisation holder Baxter Healthcare GmbH
Batch number(s) alle Chargen – die betroffenen Einheiten sind mit den angeführten Artikelcodes zu identifizieren

Baxter Artikelcodes der betroffenen Präparate
Dianeal Single Bag (SB) 2L, Dianeal Twin Bag (TB), Extraneal Single Bag/Twin Bag (SB/TB):
LPB4938R, LPB5268, RPB4938R, RPB5268, RPB5346RL, RPB9727RL, SPB4825RL, SPB4938R, SPB4953L, SPB4954L, SPB4955L, SPB5268, SPB9403L, SPB9404L, SPB9405L, SPB9407L, SPB9747RL

Dianeal 5L, Dianeal UV, Extraneal UV:
RPB5268V, SPB5215RL, SPB5225RL, SPB5235R, SPB5235RL, SPB5268V, SPB5349RL, SPB5359RL, SPB5709RL

Nutrineal Single Bag (SB), Twin Bag (TB), UV:
HPB9656G, HPB9658RG
Classification of the recall1
BASG reference number 640.297/2010
Email

Further inquiry note