Information about the temporary suspension of distribution and use of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion
10.09.2013
The Agency for Medicinal Product and Medical Devices (HALMED) has completed the special quality control of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion.
We remind that the marketing authorisation holder, Sandoz d.o.o., upon HALMED’s request initiated a temporary suspension od distribution and use of the batch CU2047 of the aforementioned medicinal product due to reports to suspected product quality that was posted on HALMED’s web site on 17 June 2013.
The testing confirms that the batch of the medicinal product in in compliance with the product specification and that the mechanical impurities are due to a particle from the inner side of the rubber stopper that fell of during the perforation with a gauge. The described fragmentation can not be completely avoided and depends upon the gauge type used for preparation/dilution of the solution for injection/infusion. The fragmentation discovered on that batch is within the range set out in the European Pharmacopoeia.
With regard to the aforementioned, the temporary suspension of distribution of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion is abolished and the product may be distributed and used.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
