The marketing authorization holder has informed the supplied customers by letter dated November 28, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA identified quality assurance deficiencies. As a precautionary measure, all batches of Velcade manufactured at BVL are now being recalled. Velcade 3.5 mg can be…

The distributor has informed the supplied institutional pharmacies in a letter dated November 25, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA has identified deficiencies in quality assurance. As a precautionary measure, all batches of Busilvex manufactured at BVL are now being recalled and replaced with…

The marketing authorization holder informed its supplied customers in a letter dated November 14, 2011, that there was misinformation in the instructions for use regarding the appearance of the tablets: the description reads salmon-colored oval tablets with a fracture notch, but the tablets are actually white, round, flattened tablets with a…

The marketing authorization holder informed its supplied customers in a letter dated November 7, 2011, that crystalline particles may be present in the amino acid chamber of the two batches mentioned and that a recall is therefore being carried out as a precautionary measure.

New confirmed case in the province of Udine.

In a letter dated November 3, 2011, the distributor informed all pharmacies, dentists and the wholesalers supplied that all batches of this medicinal product are being recalled due to possible microbial contamination with Burkholderia cepacia/stabilis.

The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children aged 16 years and younger for sedation in the context of intensive care. This is not a product warning, but a reference to the approved use. Propofol belongs to the group of drugs known as general…

The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by letter dated October 27, 2011, that all batches of the product Xigris are being recalled. The reason for this withdrawal is the results from a recently completed study that showed no statistical superiority of efficacy…

In a letter dated October 27, 2011, the marketing authorization holder informed its customers that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a short period of time. The previous reports of adverse drug reactions mainly concerned hypersensitivity…

The marketing authorization holder informed its supplied customers in a letter dated October 24, 2011, that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a short period of time. The previous reports of adverse drug reactions mainly concerned hypersensitivity…