Recall of certain batches of Norcuron 10 mg powder for solution for injection or infusion (vecuronium bromide)
Merck Sharp & Dohme d.o.o., the marketing authorisation holder for Norcuron 10 mg powder for solution for injection or infusion, has informed the Agency for Medicinal Products and Medicla Devices (HALMED) on the recall of the batches 665196 and 668521 of this medicine from wholesalers.
The recall is due to an error discovered in the Package leaflet where there was indicated that "the usual dose is 0.08 to 1 mg/kg vercuroni bromidum”, instead of "Usual dose is 0.08 to 0.1 mg/kg of vercuroni bromide”. The information on dosing in the Summary of Product Characteristics is correct.
This recall refers to the quantities of the product in wholesalers, whereas stocks that are in healthcare settings may be further used. There is another medicine from the same therapeutic group, with another active substance available for Croatian patients.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. 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 their doctor or pharmacist about the continuation of their therapy.