Tesco Flu-Max Chesty Cough & Cold Powder Recall [UK]


Tesco Flu-Max Chesty Cough & Cold Powder Recall [UK]

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UK FlagUK/London: Wrafton Laboratoires Limited (trading as Perrigo), a Wrafton, Braunton, Devon establishment, recalls certain batch/lots of Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution (GSL) PL 12063/0104 from the British marketplace due to suspected mislabeling/mispackaging and consequential incorrect dosage with consequential risks of an overdose and/or underdose hazards requiring immediate medical intervention to minimize pain and suffering as well as prevent life-changing injury

MHRA: http://ht.ly/dNaC30rX2cA

Direct link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-tesco-flu-max-all-in-one-chesty-cough-and-cold-powder-for-oral-solution-wrafton-laboratoires-limited-trading-as-perrigo-el-21-a-slash-24#brief-description-of-the-problem

Additional information:
The UK Medicines & Healthcare Products Regulatory Agency (“MHRA”) reports the following Cough & Cold Powders are subject to recall:

  • Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution (GSL) PL 12063/0104, marketed, sold and delivered with the following batch/lot designations and expiry dates:
  • Tesco Flu-Max All In One Chesty Cough & Cold Powder, sold in 10 gram sachets with a batch/lot of 9MW0145, an expiry date of Nov 2022 and a first-distributed date of 16 Mar 2020
  • Tesco Flu-Max All In One Chesty Cough & Cold Powder, sold in 10 gram sachets with a batch/lot of 0CW0054, an expiry date of Jan 2023 and a first-distributed date of 07 Apr 2020
  • Tesco Flu-Max All In One Chesty Cough & Cold Powder, sold in 10 gram sachets with a batch/lot of 0FW0133, an expiry date of May 2023 and a first-distributed date of 12 May 2021

==> No barcodes, EANs, NDCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation.

Logo - Tesco StoresAccording to the MHRA, Perrigo has recalled certain batch/lots of Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution (GSL) PL 12063/0104 from the British marketplace due to suspected mislabeling/mispackaging and consequential incorrect dosage and consequential risks of an overdose and/or underdose hazards. As a direct result of this suspected defect, you should neither serve nor consume the recalled Cough & Cold Powder identified above.

Perrigo initiated this recall due to an error on the sachet contained within the outer boxes. The sachet artwork incorrectly states that children aged 12 years and over can take up to four (4) sachets containing 1000 mg of Paracetamol (i.e., four (4) doses over a 24 hour period), whereas the carton, PIL and SmPC all correctly state that the product is not to be given to people under the age of 16.

This product should not be given to those under the age of 16.

In general, never stop taking your prescription medications without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect the drinking water supply and the ecosystem. Do not dispose of this product through your household sewer system. Instead, consult with your local chemist or city or council waste authority for disposal instructions.

Proposed Remedy:
If you believe you have purchased or have in your possession any of the recalled Cough & Cold Powder, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Cough & Cold Powder to the store where you purchased it for a full refund.

==> If you have a medical emergency, please contact 9-9-9, your closest hospital A&E or emergency centre equipped to properly treat Paracetamol overdose.

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If you have any questions, comments or complaints about this recall, please contact Perrigo Customer Services Team on 0203 598 9603 or by e-mail at UKLOCustomerService@perrigo.com.

If you have any additional questions, comments or complaints, please ring Tesco Customer Services on 0800 505 555 during normal business hours British Standard Time, Monday to Friday.

If you have any further questions, comments or complaints about this recall, please contact the UK Medicines & Healthcare Products Regulatory Agency (“MHRA”) at 020 3080 6000 during normal business hours British Standard Time, Monday to Friday or by e-mail at info@mhra.gov.uk.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Paracetamol products, please search for “Paracetamol” using the Search Box at the top of this page.

==> To see other recalls and notifications concerning Ingestion hazards, please search for “ingestion” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Wrafton Laboratoires Limited, please search for “Wrafton” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Perrigo, please search for “Perrigo” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Tesco Stores, please search for “Tesco” using the Search Box at the top of this page.

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More information about this recall:
MHRA Ref: MDR 098-10/21
Recalls Direct RIN: 15012-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
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