Official announcements
Search narrowed by
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…
Replacement
|
Medicines
|
14/04/2011
The licensee informed its supplied customers by telephone from April 12 to 14, 2011, that the valves of the affected gas cylinders are malfunctioning, so that there is a risk of under/overdosing of oxygen. The affected gas cylinders will be replaced.
Replacement
|
Medicines
|
13/04/2011
In a letter dated April 12, 2011, the marketing authorization holder informed its customers that visible particles had been detected in two batches after the expiry date of 18 months had been exceeded. As a precautionary measure, all batches that…
Recall
|
Medicines
|
01/04/2011
In a letter dated March 30, 2011, the marketing authorization holder informed its supplied customers of a precautionary recall, as isolated precipitations of the active ingredient within the shelf life of the prepared infusion solution specified in…
Replacement
|
Medicines
|
21/02/2011
The marketing authorization holder informed its supplied customers by letter dated Feb. 21, 2011, that information for use in Norwegian language was enclosed in this batch, which is intended for the drug Sarotex tablets.
Replacement
|
Medicines
|
10/02/2011
The marketing authorization holder has informed its supplied customers that results from stability data indicate a possible shortfall of the required active ingredient content by the end of the shelf life. The affected batch currently meets all…
Replacement
|
Medicines
|
03/02/2011
The marketing authorization holder informed its supplied customers in a letter dated February 3, 2011, that empty or almost empty prefilled syringes had been discovered in individual packages of the above batch and that the batch would therefore be…
Recall
|
Medicines
|
26/01/2011
The marketing authorization holder has informed its supplied customers in a letter dated January 25, 2011, that cracks have been detected in the cone of some prefilled syringes. At present, there is no indication that sterility is impaired by this…
Replacement
|
Medicines
|
26/01/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed the wholesalers supplied that all batches with the old product name "Ebixa 10mg/g Oral, Solution" will be recalled and replaced by goods with the…
Recall
|
Medicines
|
05/01/2011
Two batches of the product Dianeal have been identified that may contain endotoxins. Therefore, the marketing authorization holder has decided to recall the above mentioned batches from a dialysis center supplied in Austria.