CLASS 2 RECALL - PALEXIA ORAL SOLUTION 20MG/1ML

Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall. Due to the detection of possible Burkholderia contaminans the batches listed are being recalled as a precautionary measure. Burkholderia contaminans is a gram-negative bacterium and any potential infection may be more serious for immunocompromised patients and patients suffering from cystic fibrosis. This recall affects all batches of oral solution in the UK market that are still within their expiry date

This product is a Schedule 2 Controlled Drug, so please use the Returns Portal for any recalled stock you may need to return to ensure there is authorisation to return. If you are unable to use the Returns Portal please call Customer Services for assistance.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-grunenthal-ltd-palexia-20-mg-slash-ml-oral-solution-pl-21727-slash-0054?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ec81d6b3-a9c2-4242-ad66-27309a75a6fb&utm_content=immediately  

Further Information

For more information or medical information queries please contact +44 (0) 870 351 8960

medicalinformationuk@grunenthal.com

Grünenthal Ltd,1 Stokenchurch Business Park Ibstone Road HP14 3FE

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies

This recall will remain open for 3 months from the date issued unless an alternative date is agreed by instigator. The closure of this will be 08/05/2021. Please note after this date customer returns may still be accepted but customers may not be credited.