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Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04

Medicines Healthcare Products Regulatory Agency

February 22
13:57 2023

MDR number

MDR 133-02/23

Company name

Reckitt Benckiser Healthcare (UK) Limited

Product name

Lemsip Max Cold and Flu Capsules

PL number

PL 00063/0104

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 JAN 26 16 capsules 06 Feb 2023
AED981 1 OCT 25 8 capsules 04 Jan 2023
AEE003 1 JAN 26 8 capsules 06 Feb 2023

Active Pharmaceutical Ingredients: Paracetamol, caffeine and phenylephrine hydrochloride

Brief description of the problem

Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of the above batches of Lemsip Max Cold & Flu Capsules. The content of paracetamol per capsule was stated as 500g (grams) instead of 500mg (milligrams). The paracetamol content of each capsule is correctly stated in Patient Information Leaflet (PIL).

See images of the outer carton of the product in the Medicines Notification below.

Advice for healthcare professionals

Healthcare professionals should note that there is no risk to product quality and/or efficacy, therefore the affected batches are not being recalled.

Where queries are received regarding the discrepancy with the paracetamol content on the outer carton, healthcare professionals and retailers should signpost patients to Section 6 of the PIL, which states the correct content of paracetamol as 500mg (milligrams).

Section 6 of the PIL

Contents of the pack and other information

What this medicine contains:

  • The active ingredients are: paracetamol 500mg, caffeine 25mg and phenylephrine hydrochloride 6.1mg

Patients should also be reminded to follow the dosing instructions on the outer carton and/or Section 3 of the PIL to ensure that the recommended dose is not exceeded.

Advice for patients

This notification relates to a typographical error on end flap of the outer packaging of the affected batches of this medicine. The text on the outer pack says 500g (grams) instead of 500mg (milligrams) of paracetamol.

Patients do not need to take any action as the medicine itself is not affected, and the dosing instructions on the outer carton are correct. The company has confirmed that the content of paracetamol in each capsule within the packet is correct, and that the content of paracetamol is also correctly reflected in the Patient Information Leaflet that is packaged inside the packet.

Patients should always read the leaflet that accompanies their medicines and ask a healthcare professional if they are unsure how many capsules of the medicine they should take.

Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Further Information

For medical information and stock control queries please contact: ConsumerHealth_GB@Reckitt.com and / or 03332005345.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre10 South ColonnadeCanary WharfLondonE14 4PUTelephone +44 (0)20 3080 6574DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04

Published 22 February 2023

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