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 Number | Expiry Date | Pack Size | First Distributed |
| DO3210N, DO3410N, DO3510N | 09.2022 | 84 | 11 Jun 19 |
| DO3310N | 09.2022 | 84 | 07 Aug 19 |
| DO3610N | 10.2022 | 84 | 18 Jul 19 |
| DO3710N, DO3811N | 10.2022 | 84 | 12 Mar 19 |
| DO3911N | 10.2022 | 84 | 19 Jul 19 |
| DO4212N | 11.2022 | 84 | 19 Jul 19 |
| DO3110N | 09.2022 | 84 | 16 Apr 19 |
| DO1303N | 02.2022 | 84 | 08 Oct 18 |
| DO1003N | 02.2022 | 84 | 12 Jul 18 |
| DO0902N | 02.2022 | 84 | 12 Jul 18 |
Ibuprofen 400mg Tablets (Crescent Livery) PL 20416/0089
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 001205M | 04.2021 | 84 | 08 Aug 19 |
| DO0101O | 12.2022 | 84 | 10 Jan 20 |
| DO0503O | 02.2023 | 84 | 10 Jan 20 |
| DO4312N | 12.2022 | 84 | 25 Nov 2019 |
| DO3010N | 09.2022 | 84 | 11 Dec 2019 |
| DO1705O | 04.2023 | 84 | 07 Oct 2019 |
| DO1605O | 04.2023 | 84 | 18 Oct 2019 |
| DO1505O | 04.2023 | 84 | 01 Oct 2019 |
| DO1405O | 04.2023 | 84 | 01 Oct 2019 |
| DO1305O | 04.2023 | 84 | 27 Dec 2019 |
| DO1205O | 04.2023 | 84 | 09 Sep 2019 |
| DO1104O | 04.2023 | 84 | 27 Dec 2019 |
| DO1004O | 03.2023 | 84 | 09 Sep 2019 |
| DO0904O | 03.2023 | 84 | 21 Nov 2019 |
| DO0804O | 03.2023 | 84 | 21 Nov 2019 |
| DO0703O | 03.2023 | 84 | 15 Nov 2019 |
| DO0603O | 02.2023 | 84 | 15 Nov 2019 |
| DO0403O | 02.2023 | 84 | 15 Nov 2019 |
Flamingo Pharma (UK) Ltd
Ibuprofen 400mg Tablets (Flamingo Pharma Livery) PL 43461/0005
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1402177 | Aug-23 | 24 | Oct-18 |
| 1402268 | Sep-23 | 48 | Nov-18 |
| 1402278 | Oct-23 | 24 | Dec-18 |
| 1402308, 1402309, 1402310 | Nov-23 | 84 | Dec-18 |
| 1402316, 1402317 | Nov-23 | 84 | Jan-19 |
| 1402318 | Dec-23 | 24 | Jan-19 |
| 1402337, 1402338 | Dec-23 | 48 | Jan-19 |
| 1402363, 1402353, 1402354 | Dec-23 | 48 | Mar-19 |
| 1402352, 1402361, 1402362 | Dec-23 | 84 | Mar-19 |
| 1402368 | Jan-24 | 48 | Mar-19 |
| 1402369,1402370 | Jan-24 | 24 | Mar-19 |
| 1402424 | Mar-24 | 24 | Apr-19 |
| 1402425 | Mar-23 | 48 | Apr-19 |
| 1402543, 1402544 | Mar-24 | 48 | Jul-19 |
| 1402554 | Jun-24 | 24 | Jul-19 |
| 1402557 | Jun-24 | 84 | Aug-19 |
| 1402558, 1402559 | Jun-24 | 48 | Aug-19 |
| 1402622, 1402623 | Jul-24 | 48 | Sep-19 |
| 1402624, 1402625, 1402628 | Jul-24 | 24 | Sep-19 |
| 1402670, 1402671, 1402672, 1402673 | Aug-24 | 24 | Nov-19 |
| 1402674, 1402686, 1402687, 1402688, 1402705 | Sep-24 | 48 | Nov-19 |
| 1402706 | Sep-24 | 84 | Nov-19 |
| 1402707, 1402708 | Oct-24 | 48 | Dec-19 |
| 1402709, 1402710 | Oct-24 | 84 | Dec-19 |
| 1402711 | Nov-24 | 84 | Jan-20 |
| 1402837, 1402838 | Dec-24 | 24 | Feb-20 |
| 1402854 | Dec-24 | 48 | Feb-20 |
| 1402839, 1402852 | Dec-24 | 96 | Feb-20 |
| 1402853 | Dec-24 | 84 | Feb-20 |
Ibuprofen 400mg Tablets (TEVA Livery) PL 43461/0005
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1402172, 1402173 | Jul-23 | 84 | Sep-18 |
| 1402174, 1402175, 1402176, 1402178 | Aug-23 | 84 | Oct-18 |
| 1402279 | Nov-23 | 84 | Dec-18 |
