MHRA Class 2 Medicines Recall: Palexia 20mg/ml Oral Solution (Grünenthal)

MHRA Class 2 Medicines Recall: Palexia 20mg/ml Oral Solution (Grünenthal)

February 8, 2021

Class 2 Medicines recall: Palexia 20mg/ml Oral Solution (Grünenthal)

Drug alert number: EL (21) A/02

Date issued: 8th February 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Palexia 20mg/ml Oral Solution (Grünenthal) PL 21727/0054

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.

 

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

Advice for healthcare professionals

  • Stop supplying the batches listed above immediately.
  • Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • 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.

Full drug alert can be viewed here.

Company contacts for further information

For more information or medical information queries please contact +44 (0) 870 351 8960 or  medicalinformationuk@grunenthal.com, Grünenthal Ltd,1 Stokenchurch Business Park, Ibstone Road, HP14 3FE

 

 



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