In February 2021, Grünenthal initiated a voluntary recall of all batches of Palexia® 20 mg/ml oral solution and Palexia® 4 mg/ml oral solution due to a bacterial contamination in some batches. We have now received full approval to reintroduce these products back to the market.
The reason for the recall was a microbiological contamination with the bacterium Burkholderia contaminans, which was detected in several batches of the product Palexia® 20 mg/ml oral solution during routine stability tests. This bacteria can cause infections, particularly in immunocompromised people.
Since Palexia® 20 mg/ml oral solution and Palexia® 4 mg/ml oral solution are produced and packaged in the same facility, we could not fully rule out contamination of other batches. For this reason, both products were recalled at the patient level as a precautionary measure to ensure patient safety. The production, delivery and dispensing of the two products were stopped, and the local regulatory authorities were notified. The countries affected included Austria, Belgium, Denmark, Germany, Ireland, Italy, Norway, Sweden, Switzerland and the UK, as well as the Czech Republic, Hungary, Poland and Slovenia via our partners. The recalled batches accounted for less than 0.5 percent of the total annual production volume of Palexia®. This contamination did not affect Palexia® tablets.
Our team has now added the preservative sodium benzoate to the Palexia® 20 mg/ml oral solution as a precautionary measure. This significantly improves the product’s robustness against microbes and provides better protection for patients.
As a result, we can reintroduce these products in all of our markets. Production has already resumed, and the Palexia® 20 mg/ml oral solution will be available in countries around the globe starting from May/June 2022 (Germany and Switzerland) onwards.
The safety of our products and patients is always a top priority at Grünenthal. We can now continue to provide this important treatment to pain patients worldwide.