MHRA issues notice over Lemsip 500g typo

A typographical error on some packs of Lemsip Max Cold & Flu Capsules lists the amount of paracetamol contained per capsule as 500g rather than 500mg – well above the recommended maximum daily dose of 4g of paracetamol.
The manufacturer, RB, has confirmed that the paracetamol content of the medicine itself is correct at 500mg per capsule, and the correct information is printed on the patient information leaflet inside the box.
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The Medicines and Healthcare products Regulatory Agency has issued a Class 4 Medicines Defect Information notice over the issue, but has not recalled the packs as it says the typographical error does not affect the quality or efficacy of the medicine.
MHRA said that if healthcare professionals do receive queries about the information printed on the outside carton, they should signpost patients to Section 6 of the Patient Information Leaflet.
RB said that the error occurred after a recent packaging design upgrade and has been corrected on ongoing productions.
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The manufacturer added: 'We would like to reassure consumers that the detail contained on all patient information leaflets inside the boxes is accurate and contains 500mg of paracetamol, with no changes to the composition of the capsules. We encourage consumers to always refer to the information leaflet provided with any medicine and ask their healthcare professional if they have any concerns.'
The error affects nine batches distributed since 4 January 2023:
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Batch number | Expiry date | Pack size | First distributed |
AED954 | 1 Dec 25 | 16 capsules | 24 Jan 2023 |
AED955 | 1 Dec 25 | 16 capsules | 17 Jan 2023 |
AED956 | 1 Dec 25 | 16 capsules | 25 Jan 2023 |
AED957 | 1 Jan 26 | 16 capsules | 17 Jan 2023 |
AED958 | 1 Jan 26 | 16 capsules | 30 Jan 2023 |
AED960 | 1 Jan 26 | 16 capsules | 06 Feb 2023 |
AED961 | 1 Jan26 | 16 capsules | 06 Feb 2023 |
AED981 | 1 Oct 25 | 8 capsules | 04 Jan 2023 |
AEE003 | 1 Jan 26 | 8 capsules | 06 Feb 2023 |
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Oops RB! How have your QC missed that typo? By the way, is the assumption that every Lemsip purchaser would read the PIL? Or would it be more ethical (and yes, expensive) for RB to voluntarily recall the affected batches. If not, what precedent are the MHRA inadvertently enabling?