Replacement | Medicines | 14/12/2011

The marketing authorization holder has informed its supplied customers by letter dated 14.12.2011 that the above mentioned batches have to be recalled due to a potential contamination with particles. This problem was identified during a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA.

Name of the medicinal product Vistide 75 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Marketing authorisation number(s) EU/1/97/037/001
Marketing authorisation holder Gilead Sciences International Limited

Durchführung Austausch:
Gilead Sciences GesmbH
Batch number(s) 1797701D, 1797701D1, 1797701D2, 1797701D3
Classification of the recall2
BASG reference number INS-640.001-0310

Further inquiry note