ZentroOlimel
Replacement
|
Medicines
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25/03/2014
The marketing authorization holder informed its supplied customers in a letter dated March 21, 2014, that an internal review determined that the regulatory approved limit for bacterial endotoxins (BET) for this drug product is higher than the limit of 5 EU/kg/hr specified in the European Pharmacopoeia (Ph. Eur.), section 5.1.10. However, the approved BET limit for adults is in compliance with Ph.Eur. The affected batch 12F27N11 was released according to the approved limit, but exceeds the more stringent Ph. Eur. limit, which covers all patient groups (adults and children over 2 years of age) for which the product is approved. Therefore, as a precautionary measure, the above batch will be withdrawn from the market as of 05/2014.
| Name of the medicinal product | ZentroOLIMEL 5,7 % - Emulsion zur Infusion |
|---|---|
| Marketing authorisation number(s) | 1-29006 |
| Marketing authorisation holder | Baxter Healthcare GmbH |
| Batch number(s) | 12F27N11 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1061 |
Further inquiry note
Page last modified:
12/07/2022