Skip to content
Search

Latest Stories

MHRA drug alert for Ibuprofen 400 mg tablets

pharmacy.biz Staff
By pharmacy.biz StaffFeb 24, 2020
pharmacy.biz Staff
See Full Bio

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for Ibuprofen 400 mg tablets.

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed the government agency that Patient Information Leaflet (PIL) within their packs of certain pharmacy (P) batches are incorrect.

The PIL in these batches includes incorrect dosing instructions in Section 3, How to take Ibuprofen. The leaflet incorrectly states that ‘The maximum daily dose should not exceed 6 [six] tablets (2400 mg)'.

The correct statement is: ‘The maximum daily dose should not be more than 3 tablets (1200 mg)'.

“This dosing regimen should only be given to patients who are under the supervision of their GP or healthcare prescriber and have been prescribed Ibuprofen 400mg Tablets. The outer carton contains the correct P indications and posology,” the MHRA statement read.

Pharmacists are asked to check the Marketing Authorisation Holder and the batch number while dispensing or providing the product over the counter and ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling.

MHRA further suggested to dispense these batches against a prescription rather than sold over the counter to safeguard patients from taking a prescription-only dose.

Product details:

Crescent Pharma Ltd

Ibuprofen 400mg Tablets (Almus Livery) PL 20416/0089

Batch NumberExpiry DatePack SizeFirst Distributed
DO3210N, DO3410N, DO3510N09.20228411 Jun 19
DO3310N 09.20228407 Aug 19
DO3610N10.20228418 Jul 19
DO3710N, DO3811N10.20228412 Mar 19
DO3911N10.20228419 Jul 19
DO4212N11.20228419 Jul 19
DO3110N09.20228416 Apr 19
DO1303N02.20228408 Oct 18
DO1003N02.20228412 Jul 18
DO0902N02.20228412 Jul 18

Ibuprofen 400mg Tablets (Crescent Livery) PL 20416/0089

Batch NumberExpiry DatePack SizeFirst Distributed
001205M04.20218408 Aug 19
DO0101O12.20228410 Jan 20
DO0503O02.20238410 Jan 20
DO4312N12.20228425 Nov 2019
DO3010N09.20228411 Dec 2019
DO1705O04.20238407 Oct 2019
DO1605O 04.20238418 Oct 2019
DO1505O 04.20238401 Oct 2019
DO1405O 04.20238401 Oct 2019
DO1305O 04.20238427 Dec 2019
DO1205O 04.20238409 Sep 2019
DO1104O 04.20238427 Dec 2019
DO1004O 03.20238409 Sep 2019
DO0904O03.20238421 Nov 2019
DO0804O03.20238421 Nov 2019
DO0703O03.20238415 Nov 2019
DO0603O02.20238415 Nov 2019
DO0403O02.20238415 Nov 2019

Flamingo Pharma (UK) Ltd

Ibuprofen 400mg Tablets (Flamingo Pharma Livery) PL 43461/0005

Batch NumberExpiry DatePack SizeFirst Distributed
1402177Aug-2324Oct-18
1402268Sep-2348Nov-18
1402278Oct-2324Dec-18
1402308, 1402309, 1402310Nov-2384Dec-18
1402316, 1402317Nov-2384Jan-19
1402318Dec-2324Jan-19
1402337, 1402338Dec-2348Jan-19
1402363, 1402353, 1402354Dec-2348Mar-19
1402352, 1402361, 1402362Dec-2384Mar-19
1402368Jan-2448Mar-19
1402369,1402370Jan-2424Mar-19
1402424Mar-2424Apr-19
1402425Mar-2348Apr-19
1402543, 1402544Mar-2448Jul-19
1402554Jun-2424Jul-19
1402557Jun-2484Aug-19
1402558, 1402559Jun-2448Aug-19
1402622, 1402623Jul-2448Sep-19
1402624, 1402625, 1402628Jul-2424Sep-19
1402670, 1402671, 1402672, 1402673Aug-2424Nov-19
1402674, 1402686, 1402687, 1402688, 1402705Sep-2448Nov-19
1402706Sep-2484Nov-19
1402707, 1402708Oct-2448Dec-19
1402709, 1402710Oct-2484Dec-19
1402711Nov-2484Jan-20
1402837, 1402838Dec-2424Feb-20
1402854Dec-2448Feb-20
1402839, 1402852Dec-2496Feb-20
1402853Dec-2484Feb-20

Ibuprofen 400mg Tablets (TEVA Livery) PL 43461/0005

Batch NumberExpiry DatePack SizeFirst Distributed
1402172, 1402173Jul-2384Sep-18
1402174, 1402175, 1402176, 1402178Aug-2384Oct-18
1402279Nov-2384Dec-18

Related News

NHS to roll out RSV vaccinations across 200 pharmacies in 2025/26
News

RSV vaccination pilot to expand to 200 pharmacies in 2025/26

RPS backs Pharmacist Support "Gift in Wills" initiative
News

Leave a legacy: RPS partners with Pharmacist Support to promote ‘Gift in Wills’

Pharmacy Business Conference is a must-attend for contractors — Here’s why

What I took away from the Pharmacy Business Conference 2025

Off-patent medicines could save NHS millions—but only if UK remains attractive to suppliers - BGMA
Features

UK risks losing millions in NHS savings without stronger support for generics - BGMA

More For You

Pharmacist Support calls for birthday donations to meet rising demand for mental health services

More and more pharmacy professionals are reaching out for help, said Danielle Hunt.

Pharmacist Support's birthday appeal: Donate to address growing mental health demand

Pharmacist Support – the independent charity dedicated to the pharmacy profession – is celebrating 184 years of service with the launch of a special birthday donations appeal.

On 15 April, the charity is urging individuals and organisations across the sector to support its campaign to raise vital funds to meet the increasing demand for its mental health and wellbeing services.

Keep ReadingShow less
Prostate cancer: At-home saliva test could save NHS £500 million annually

PRS saliva test can identify prostate cancer that was missed by an MRI scan

Photo credit: gettyimages

Prostate cancer: Spit test better than blood test in spotting men at highest risk

A simple at-home spit test could help detect prostate cancer earlier, saving the NHS around £500 million a year, according to new research published in the New England Journal of Medicine.

Funded by the National Institute for Health and Care Research (NIHR), the study found that the DNA-based saliva test was more accurate than the current prostate-specific antigen (PSA) blood test in identifying men at risk of developing prostate cancer.

Keep ReadingShow less
RPS launches innovative new learning resources for members

With RPS Learn, pharmacists can develop a new skill or improve their understanding of practice or a clinical topic.

Gettyimages

RPS launches new learning resources to boost career development for members

The Royal Pharmaceutical Society (RPS) has launched a new online learning platform designed to support the practice, development and career advancement of its members.

The new platform, called RPS Learn, offers a diverse range of bite-size learning content, available on-demand, catering to all levels — from introductory to advanced and specialist —combining new content with RPS's renowned expertise in education and training to achieve excellence for learners.

Keep ReadingShow less
NICE approves AstraZeneca’s twice-a-day tablet ‘capivasertib’ for advanced breast cancer

HR-positive, HER2-negative advanced breast cancer is currently incurable, and treatment aims to slow progression and prolong life

Gettyimages

NICE approves twice-a-day tablet for advanced breast cancer

Every year, thousands of people with hormone receptor (HR)-positive HER2-negative breast cancer could benefit from a new twice-a-day tablet, now set to be funded immediately through the Cancer Drugs Fund.

The National Institute for Health and Care Excellence (NICE) has approved the use of capivasertib (also known as Truqap), in combination with fulvestrant, as an option for around 1,100 adults with HR-positive HER2-negative breast cancer that has certain genetic mutations and has spread.

Keep ReadingShow less
ABPI and government fast-track VPAG scheme review to address high medicine payment rates

The 2025 VPAG payment rate for newer medicines has been set at 22.9 per cent.

Photo credit: gettyimages

Review of 2024 VPAG scheme to be completed by June

The Association of the British Pharmaceutical Industry (ABPI) and the government have agreed to bring forward a planned review of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG), originally scheduled for autumn 2025.

The review is expected to be completed in June 2025, aligning with the anticipated release of the government’s 10-year NHS Plan and the Life Sciences Sector Plan as part of the broader industry strategy this summer.

Keep ReadingShow less
© Copyright 2025 Garavi Gujarat Publications Ltd & Garavi Gujarat Publications USA Inc