Official announcements
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Replacement
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Medicines
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11/05/2011
The marketing authorization holder informed its supplied customers in a letter dated May 11, 2011, that due to reports of an unpleasant, moldy odor, the affected batches must be recalled. This odor emanates from the primary packaging (plastic…
Replacement
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Medicines
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05/05/2011
The marketing authorization holder informed its supplied customers by letter dated May 3, 2011, that an atypically elevated value of a known, characterized degradation product was detected in the batches listed above. However, the values are within…
Medicines
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05/05/2011
Decree concerning "Standards for the preparation for use, application and disposal of cytostatic drugs" (acc. to § 2 Z 12 GQG). See related files.
Replacement
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Medicines
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29/04/2011
In a letter dated April 29, 2011, the marketing authorization holder informed its customers that the two batches had to be exchanged because routine stability tests had revealed that the test values for active ingredient release and disintegrability…
Replacement
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Medicines
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28/04/2011
The marketing authorization holder has informed its supplied customers by letter dated April 28, 2011, that a small piece of glass has been detected in a vial of the above mentioned batch. As a precaution, Mallinckrodt/Covidien (NL) is recalling the…
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…
Replacement
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Medicines
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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
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Medicines
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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
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Medicines
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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
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Medicines
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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.