Peritoneal dialysis solutions
Replacement
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Medicines
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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 recall | 1 |
| BASG reference number | 640.297/2010 |
Further inquiry note
Page last modified:
12/07/2022