Voluntary Recall of Iliadin® Solution 0.025%, Iliadin® Solution 0.05%, Iliadin® Spray 0.05%, Iliadin® Solution for Nose 0.01%

Merck would like to inform healthcare professionals of the voluntary recall of selected batches of Iliadin® Solution 0.025%, Iliadin® Solution 0.05%, Iliadin® Spray 0.05% and Iliadin® Solution for Nose 0.01% due to isolated instances of microbiological impurities being identified near the end of the products' shelf life or upon expiry. During routine testing, isolated instances of microbiological impurities were identified in a few batches of Iliadin products manufactured before June 2012. A review of the manufacturing and steaming operation of the filling tank had identified the source of microbial impurities to be purified water used for chilling of the filling tank, of which a possible back flow into the filling tank may have resulted in the contamination. As a precautionary measure, Merck is initiating an immediate voluntary recall of all batches of Iliadin® Solution 0.025%, Iliadin® Solution 0.05%, Iliadin® Spray 0.05% and Iliadin® Solution for Nose 0.01% manufactured before June 2012. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for further details.