Recall of a Duodopa intestinal gel (20 mg/ml levodopa and 5 mg/ml carbidopa) lot


Due to suspected quality defect, the Agency for Medicinal Products and Medical Devices on 9 February 2010 recalled one lot (no. 09J26G11) of the medicinal product Duodopa intestinal gel (20 mg/ml levodopa and 5 mg/ml carbidopa), manufactured by Solvay Pharmaceuticals GmbH, Germany.

The defect of the said lot number manifested as phase separation of the gel. In addition to Croatia, this relevant lot of this medicinal product was also distributed in the countries of the European Union.

Duodopa intestinal gel is indicated for treatment of Parkinson's disease and it may be dispensed only on prescription and in specialised health institutions. 100 ml of intestinal gel is provided in a PVC bag with a plastic tube and a pump inside a hard plastic cassette. One box contains seven cassettes.

The Agency informed all hospital institutions to stop using the said lot of the medicinal product Duodopa intestinal gel. In line with the Agency's request, the marketing authorisation holder for Croatia, Solvay Pharma d.o.o., has the obligation to replace the said lot by another one, thus ensuring continuous therapy for patients.