On Tuesday of last week, Grünenthal initiated a recall of all batches of Palexia® 20 mg/ml oral solution and Palexia® 4 mg/ml oral solution and halted production until further notice due to a bacterial contamination issue. Palexia® tablets are not affected by the contamination and are not being recalled.
The reason for the recall is a microbiological contamination with the bacterium Burkholderia contaminans in several batches of the product Palexia® 20 mg/ml oral solution, which was detected during routine stability tests. The bacteria can lead to infections, particularly in immunocompromised individuals. Since Palexia® 20 mg/ml oral solution and Palexia® 4 mg/ml oral solution are produced and packaged in the same filling facility and contamination of other batches cannot be ruled out, both products are being recalled at patient level as a precautionary measure to ensure patient safety. The delivery and dispensing of the two products has been stopped and the local regulatory authorities have been notified. Countries affected are Austria, Belgium, Switzerland, Germany, Denmark, Norway, France, UK, Ireland, Italy, Sweden and via our partners Hungary, Poland, Slovenia and the Czech Republic. The amount of batches being recalled accounts for less than 0.5 percent of the total annual production volume of Palexia®.
The safety of our products and patients is always a top priority at Grünenthal. We are working in close collaboration with the responsible authorities to protect patient safety.
Head External Communications and Editorial Management
Phone +49 241 569-3269