The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall alert for Palexia 20mg/ml oral solution.
The drug manufacturer Grünenthal Ltd has alerted of a potential microbial contamination during routine stability testing for the batches listed in the recall. Due to the detection of possible Burkholderia contaminans the batches listed below 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.
|Batch Number||Expiry Date||Pack Size||First Distributed|
|00203N||02.2022||1 x 200ml||12.02.2018|
|00608N||02.2022||1 x 200ml||15.05.2018|
|00797N||02.2022||1 x 200ml||18.09.2018|
|01541l||02.2022||1 x 100ml||18.12.2017|
|00201N||02.2022||1 x 100ml||12.02.2018|
|00605N||02.2022||1 x 100ml||15.05.2018|
|00607N||02.2022||1 x 100ml||02.07.2018|
|01111N||02.2022||1 x 100ml||28.09.2018|
|01568N||04.2022||1 x 100ml||14.01.2019|
|00966P||04.2024||1 x 100ml||17.09.2019|
|01242P||04.2024||1 x 100ml||30.10.2019|
|01230P||06.2024||1 x 100ml||30.10.2019|
|01416P||06.2024||1 x 100ml||07.01.2020|
|00448R||01.2025||1 x 100ml||16.04.2020|
|01104R||02.2025||1 x 100ml||12.10.2020|
|01631R||09.2025||1 x 100ml||16.12.2020|
This medicine is intended for acute pain situations. Whilst the product has a five-year shelf-life unopened, the bottle(s), once opened, should be used within six weeks.
Community pharmacists have been suggested to stop supplying the affected batches immediately and quarantine all remaining stock to return it to the concerned supplier.
Pharmacists should contact all patients who have been dispensed this product between December 2017 to February 2021 to determine if any patients have the affected batches within their possession and to return these to the pharmacy as part of this recall.
“If patients are confirmed to have the bottle(s) from the affected batches in their possession and they are currently administering dose, they should be signposted to this alert and informed to immediately contact their GP/prescriber to consider withdrawal of the product, tapering of the dose and any suitable clinical alternatives,” the MHRA said.