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.

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…

The distribution company informed its supplied customers on 04/16/2014 and asked for a stock check of the affected batch.

European Medicines Agency warns against counterfeit Herceptin

The distributor informed its supplied customers in a letter dated 14.04.2014 that deposits and precipitations may occur in the injection vials. According to the specification, the suspension should be able to be resuspended within one minute by…

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…

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…

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…

Ebola hemorrhagic fever outbreak in Guinea.

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…