Official announcements
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Safety warnings
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Medicines
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16/04/2014
The European Medicines Agency received information that vials of Herceptin, a drug used to treat cancer, were adulterated and introduced into the legal distribution chain.
Replacement
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Medicines
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16/04/2014
The parallel distributor has informed its supplied customers in a letter dated 16.04.2014 that Herceptin in Italian presentation has been adulterated and introduced into the legal distribution chain. Therefore, a recall of the above mentioned Italian…
Recall
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Medicines
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16/04/2014
The distribution company informed its supplied customers on 04/16/2014 and asked for a stock check of the affected batch.
Replacement
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Medicines
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14/04/2014
The marketing authorization holder has informed its wholesalers in a letter dated April 11, 2014, that the contract manufacturer for "Paroxetine-ratiopharm 20 mg Film-Coated Tablets" has received a "Warning letter" from the FDA (US Food and Drug…
Replacement
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Medicines
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14/04/2014
The marketing authorization holder informed its wholesalers in a letter dated April 10, 2014, that GlaxoSmithKline (GSK) had received a warning letter from the FDA (US Food and Drug Administration) with concerns about the release of the active…
Replacement
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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…
Replacement
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Medicines
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21/03/2014
The marketing authorization holder informed its supplied customers in a letter dated March 20, 2014, that isolated blisters of Calmolan 0.18 mg (packs of 30 / 3 blisters) may have been incorrectly packaged and labeled with an outer label of Calmolan…
Recall
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Medicines
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20/03/2014
The marketing authorization holder informed its supplied customers in a letter dated 19.03.2014 that underfilling of the15 ml package size had been detected. This is not a case of underfilling during production, but of evaporation of the alcohol due…
Recall
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Medicines
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14/03/2014
"Janssen-Cilag Pharma GmbH" informed its supplied customers in a letter dated March 13, 2014, that due to continuous assessment of the product portfolio and return of the license to Shionogi & Co, Ltd, the Group has decided to recall "Doribax 500 mg…
Replacement
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Medicines
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13/03/2014
Madaus Ges.m.b.H." has informed its supplied customers by letter dated 11.03.2014 that within the framework of ongoing stability tests, quality deviations have been detected which represent a microbiological contamination and therefore a recall will…