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13 October 2021 by Jacquie Lee

Class 2 Medicines Recall: Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution Wrafton Laboratoires Limited (trading as Perrigo)

  • Wales
  • England
  • Scotland
  • Northern Ireland

Perrigo are recalling batches of Tesco Flu-Max All In One Chesty Cough & Cold Powder due to an error on the sachet contained within the outer carton.

MDR Number MDR 098-10/21

Company name Wrafton Laboratoires Limited (trading as Perrigo)

Product description Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution (GSL) PL 12063/0104

Details of the affected batches:

Batch Number

Expiry Date

Pack Size

First Distributed

9MW0145

Nov 2022

10s

16 Mar 2020

0CW0054

Jan 2023

10s

07 Apr 2020

0FW0133

May 2023

10s

12 May 2021

Brief description of problem

Perrigo are recalling the above batches due to an error on the sachet contained within the outer carton. The sachet artwork incorrectly states that children aged 12 years and over can take 4 sachets containing 1000mg of paracetamol (i.e. 4 doses over a 24 hour period), whereas the carton, PIL and SmPC state that the product is not to be given to the under 16s. The sachets dosage instructions are those which were in use prior to the paediatric paracetamol posology update implemented by the MHRA.

The correct posology instruction on the outer carton, patient information leaflet (PIL) and summary of product characteristics (SmPC) comply with regulatory requirements but differ from that on the product sachet which is incorrect. See link to PIL containing the correct information.

This product should not be given to under 16s and therefore the product is being recalled from patients directly.

This product is only sold from Tesco stores directly and does not impact any other products that share the PL number, but packaged in different liveries. If you have any concerns, please contact Perrigo using the details below.

Advice for patients and consumers

  • Stop using the product immediately and return this to Tesco Stores.
  • If you experience any side-effects, or have any questions or concerns about your health, speak to your doctor or pharmacist.
  • Report any suspected side effects via the Yellow Card Scheme

 Advice to Healthcare Professionals

  • Advise patients who have been supplied this product to stop using the product immediately and return this to Tesco Stores, where appropriate.
  • Any suspected side effects should be reported via the Yellow Card Scheme.

Company contacts for further information

For more information, please contact: Perrigo Customer Services Team on 0203 598 9603 or UKLOCustomerService@perrigo.com

For stock control queries, please contact: Perrigo Service Team on 01226 704711 or customerservice@perrigouk.com

To access the full recall: Class 2 Medicines Recall: Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution EL (21)A/24

Drug alert class 2

Drug alert class 2

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