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 shaking, which is not guaranteed due to the quality defect.

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 Administration) with concerns regarding the release of the active ingredient "Paroxetine". This affects…

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 ingredient paroxetine. Batches of the active ingredient produced at GSK's Cork, Ireland facility between…

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…

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 0.35 mg. Thus, there is a possibility that packages labeled Calmolan 0.35 mg and lot numbers…

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 to drip fittings not fitting tightly. This evaporation subsequently leads to a concentration of the…

"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 Powder for the Preparation of an Infusion Solution" from all markets worldwide.

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 be carried out.

The distributor has informed its supplied customers in a letter dated March 5, 2014, that ten batches were identified during investigations that showed an increased risk of out-of-specification (OOS) values for the parameter "polymers, aggregates and fragments" before expiry of shelf life. Only one batch (batch C1274, not marketed in Austria)…