Class 4 Drug Alert: Ibuprofen 400mg Tablets (Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd) – update

Class 4 Drug Alert: Ibuprofen 400mg Tablets (Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd) – update

February 24, 2020

Drug alert number: EL (20)A/10

Date issued: 20 February 2020 – updated 24th February 2020 with further batches

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Crescent Pharma Ltd, Flamingo Pharma (Uk) Ltd, Ibuprofen 400mg Tablets (Various Liveries)

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed the MHRA that the Patient Information Leaflet (PIL) within their packs of pharmacy (P) batches listed below are incorrect. The PIL in the below listed 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).’ 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.

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

Advice for healthcare professionals

When dispensing or providing this product over the counter, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling.

• Correct statement: The maximum daily dose should not be more than 3 [three] tablets (1200 mg).

Where possible, these packs should be considered to be dispensed against a prescription rather than sold over the counter to safeguard patients from taking a prescription only dose.

Full details of the drug alert can be viewed here.

Further Information

Crescent Pharma Ltd.
• For updated PIL information, please click here.
• For more information or medical information queries, please contact: Crescent Pharma Ltd. Medical Information Department on +00351 214643225, via email on tiago.barca@pharsolution.com or +44 (0) 1256 772740.

Flamingo Pharma (UK) Ltd.
• For more information or medical information queries, please contact: Flamingo Pharma (UK) Ltd on +44 (0) 7733 522465

 



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